Bruce Jancin

Major Finding: During a peak cardiopulmonary exercise test, all 10 diabetic subjects demonstrated a significantly greater mean increase in pulmonary capillary wedge pressure, compared with controls (23.6 mm Hg versus 16.7 mm Hg).

Data Source: A series of observational studies that involved sedentary patients with and without diabetes.

Disclosures: Dr. Regensteiner declared having no financial conflicts.

KEYSTONE, COLO. – Regular physical activity is a cornerstone of the treatment of type 2 diabetes, yet patients with the disease often have an impaired ability to exercise even in the absence of clinically evident coronary heart disease.

It's a catch-22 situation. Recent studies suggest a couple of explanations for this impaired ability to exercise, vs. that of sedentary nondiabetic controls. One, subclinical cardiac dysfunction during exercise is present quite early in the course of type 2 diabetes. Two, patients with type 2 diabetes perceive even a very low exercise workload as requiring much more effort than do matched controls, Judith G. Regensteiner, Ph.D., said at the conference, sponsored by the University of Colorado and the Children's Diabetes Foundation at Denver.

She and her coworkers studied 10 premenopausal women with type 2 diabetes and 10 healthy but equally sedentary controls in the cardiac catheterization lab. Their purpose was to learn why the disease is associated with reduced peak exercise capacity as expressed via peak oxygen uptake. The diabetic subjects had been diagnosed an average of 3.6 years earlier, and all were free of clinical cardiovascular disease.

Resting measurements of cardiac hemodynamics assessed via an indwelling pulmonary artery catheter were similar in diabetic subjects and controls. However, during a peak cardiopulmonary exercise test one glaring difference between the groups became evident: All 10 diabetic subjects had a significantly greater increase in pulmonary capillary wedge pressure than controls. The mean increase was 23.6 mm Hg in the diabetic subjects compared to 16.7 mm Hg in controls.

“This was a most startling result. It showed evidence of a stiff heart suggestive of diastolic dysfunction in people who'd been diagnosed with diabetes only 3.6 years earlier. It's a scary finding,” said Dr. Regensteiner, professor of medicine and director of the Center for Women's Health at the University of Colorado.

On another day the investigators performed myocardial perfusion imaging using technetium-99m sestamibi in seven subjects in each group during peak exercise. The normalized myocardial perfusion index was significantly diminished in the diabetic patients: a mean of 11.0 compared to 17.5 × e-9 in controls. This is indicative of significantly less blood flow to the heart in the diabetic group. The myocardial perfusion index was inversely related to pulmonary capillary wedge pressure during peak exercise.

The investigators restricted this study to women because the gap in exercise tolerance between diabetic women and men is greater than between nondiabetic women and men.

Dr. Regensteiner and coworkers are now studying leg muscle blood flow to learn if abnormalities in peripheral circulation also contribute to exercise intolerance in patients with type 2 diabetes.

Another barrier to physical activity on the part of patients with type 2 diabetes may be mental. In a separate study, she and her coinvestigators utilized a standardized rate-of-perceived-exertion scale to study 13 women with type 2 diabetes and a mean body mass index of 34.2 kg/m

These are very modest workloads. Indeed, the two groups of nondiabetic controls barely perceived them as workloads at all. The diabetic subjects perceived the physical effort as being much greater than did either control group.

“Is it all in the head? I don't know. We're looking now to see if there are things about having diabetes that may make patients perceive low-intensity exercise as being more difficult physiologically,” Dr. Regensteiner said.

Simple walking provides effective aerobic exercise for patients with diabetes.

Source ©Monkey Business/Fotolia.com

Major Finding: During a peak cardiopulmonary exercise test, all 10 diabetic subjects demonstrated a significantly greater mean increase in pulmonary capillary wedge pressure, compared with controls (23.6 mm Hg versus 16.7 mm Hg).

Data Source: A series of observational studies that involved sedentary patients with and without diabetes.

Disclosures: Dr. Regensteiner declared having no financial conflicts.

KEYSTONE, COLO. – Regular physical activity is a cornerstone of the treatment of type 2 diabetes, yet patients with the disease often have an impaired ability to exercise even in the absence of clinically evident coronary heart disease.

It's a catch-22 situation. Recent studies suggest a couple of explanations for this impaired ability to exercise, vs. that of sedentary nondiabetic controls. One, subclinical cardiac dysfunction during exercise is present quite early in the course of type 2 diabetes. Two, patients with type 2 diabetes perceive even a very low exercise workload as requiring much more effort than do matched controls, Judith G. Regensteiner, Ph.D., said at the conference, sponsored by the University of Colorado and the Children's Diabetes Foundation at Denver.

She and her coworkers studied 10 premenopausal women with type 2 diabetes and 10 healthy but equally sedentary controls in the cardiac catheterization lab. Their purpose was to learn why the disease is associated with reduced peak exercise capacity as expressed via peak oxygen uptake. The diabetic subjects had been diagnosed an average of 3.6 years earlier, and all were free of clinical cardiovascular disease.

Resting measurements of cardiac hemodynamics assessed via an indwelling pulmonary artery catheter were similar in diabetic subjects and controls. However, during a peak cardiopulmonary exercise test one glaring difference between the groups became evident: All 10 diabetic subjects had a significantly greater increase in pulmonary capillary wedge pressure than controls. The mean increase was 23.6 mm Hg in the diabetic subjects compared to 16.7 mm Hg in controls.

“This was a most startling result. It showed evidence of a stiff heart suggestive of diastolic dysfunction in people who'd been diagnosed with diabetes only 3.6 years earlier. It's a scary finding,” said Dr. Regensteiner, professor of medicine and director of the Center for Women's Health at the University of Colorado.

On another day the investigators performed myocardial perfusion imaging using technetium-99m sestamibi in seven subjects in each group during peak exercise. The normalized myocardial perfusion index was significantly diminished in the diabetic patients: a mean of 11.0 compared to 17.5 × e-9 in controls. This is indicative of significantly less blood flow to the heart in the diabetic group. The myocardial perfusion index was inversely related to pulmonary capillary wedge pressure during peak exercise.

The investigators restricted this study to women because the gap in exercise tolerance between diabetic women and men is greater than between nondiabetic women and men.

Dr. Regensteiner and coworkers are now studying leg muscle blood flow to learn if abnormalities in peripheral circulation also contribute to exercise intolerance in patients with type 2 diabetes.

Another barrier to physical activity on the part of patients with type 2 diabetes may be mental. In a separate study, she and her coinvestigators utilized a standardized rate-of-perceived-exertion scale to study 13 women with type 2 diabetes and a mean body mass index of 34.2 kg/m

These are very modest workloads. Indeed, the two groups of nondiabetic controls barely perceived them as workloads at all. The diabetic subjects perceived the physical effort as being much greater than did either control group.

“Is it all in the head? I don't know. We're looking now to see if there are things about having diabetes that may make patients perceive low-intensity exercise as being more difficult physiologically,” Dr. Regensteiner said.

Simple walking provides effective aerobic exercise for patients with diabetes.

Source ©Monkey Business/Fotolia.com

Major Finding: During a peak cardiopulmonary exercise test, all 10 diabetic subjects demonstrated a significantly greater mean increase in pulmonary capillary wedge pressure, compared with controls (23.6 mm Hg versus 16.7 mm Hg).

Data Source: A series of observational studies that involved sedentary patients with and without diabetes.

Disclosures: Dr. Regensteiner declared having no financial conflicts.

KEYSTONE, COLO. – Regular physical activity is a cornerstone of the treatment of type 2 diabetes, yet patients with the disease often have an impaired ability to exercise even in the absence of clinically evident coronary heart disease.

It's a catch-22 situation. Recent studies suggest a couple of explanations for this impaired ability to exercise, vs. that of sedentary nondiabetic controls. One, subclinical cardiac dysfunction during exercise is present quite early in the course of type 2 diabetes. Two, patients with type 2 diabetes perceive even a very low exercise workload as requiring much more effort than do matched controls, Judith G. Regensteiner, Ph.D., said at the conference, sponsored by the University of Colorado and the Children's Diabetes Foundation at Denver.

She and her coworkers studied 10 premenopausal women with type 2 diabetes and 10 healthy but equally sedentary controls in the cardiac catheterization lab. Their purpose was to learn why the disease is associated with reduced peak exercise capacity as expressed via peak oxygen uptake. The diabetic subjects had been diagnosed an average of 3.6 years earlier, and all were free of clinical cardiovascular disease.

Resting measurements of cardiac hemodynamics assessed via an indwelling pulmonary artery catheter were similar in diabetic subjects and controls. However, during a peak cardiopulmonary exercise test one glaring difference between the groups became evident: All 10 diabetic subjects had a significantly greater increase in pulmonary capillary wedge pressure than controls. The mean increase was 23.6 mm Hg in the diabetic subjects compared to 16.7 mm Hg in controls.

“This was a most startling result. It showed evidence of a stiff heart suggestive of diastolic dysfunction in people who'd been diagnosed with diabetes only 3.6 years earlier. It's a scary finding,” said Dr. Regensteiner, professor of medicine and director of the Center for Women's Health at the University of Colorado.

On another day the investigators performed myocardial perfusion imaging using technetium-99m sestamibi in seven subjects in each group during peak exercise. The normalized myocardial perfusion index was significantly diminished in the diabetic patients: a mean of 11.0 compared to 17.5 × e-9 in controls. This is indicative of significantly less blood flow to the heart in the diabetic group. The myocardial perfusion index was inversely related to pulmonary capillary wedge pressure during peak exercise.

The investigators restricted this study to women because the gap in exercise tolerance between diabetic women and men is greater than between nondiabetic women and men.

Dr. Regensteiner and coworkers are now studying leg muscle blood flow to learn if abnormalities in peripheral circulation also contribute to exercise intolerance in patients with type 2 diabetes.

Another barrier to physical activity on the part of patients with type 2 diabetes may be mental. In a separate study, she and her coinvestigators utilized a standardized rate-of-perceived-exertion scale to study 13 women with type 2 diabetes and a mean body mass index of 34.2 kg/m

These are very modest workloads. Indeed, the two groups of nondiabetic controls barely perceived them as workloads at all. The diabetic subjects perceived the physical effort as being much greater than did either control group.

“Is it all in the head? I don't know. We're looking now to see if there are things about having diabetes that may make patients perceive low-intensity exercise as being more difficult physiologically,” Dr. Regensteiner said.

Simple walking provides effective aerobic exercise for patients with diabetes.

Source ©Monkey Business/Fotolia.com

Major Finding: The annual combined rate of cardiovascular death or nonfatal MI was 2.4% in a prospective series of diabetes patients with stable symptoms suggestive of CAD.

Data Source: A consecutive series of 444 patients followed for a median of 2.4 years.

Disclosures: Dr. Bourque said he had no financial conflicts.

DENVER – Diabetes patients with stable symptoms of coronary artery disease appear to have a lower cardiac event risk than previously thought.

The yearly rate of cardiovascular death or nonfatal MI was just 2.4% in a series of 444 consecutive diabetes outpatients with symptoms suggestive of coronary artery disease (CAD) who underwent exercise treadmill or pharmacologic stress single-photon emission computed tomography (SPECT) myocardial perfusion imaging. The cardiovascular death rate of 0.4% per year and the nonfatal MI rate of 2.0% per year were surprisingly low, given that 39% of subjects had known CAD and the rest had symptoms suggestive of CAD, Dr. Jamieson M. Bourque noted at the meeting.

The explanation may be found at least in part in contemporary evidence-based intensive medical management for risk reduction in this traditionally high-risk population, added Dr. Bourque of the University of Virginia, Charlottesville.

Of the 444 symptomatic diabetes patients, 78.5% had no inducible ischemia on stress SPECT myocardial perfusion imaging, 16.5% had 1%-9% left ventricular ischemia, and 5% had left ventricular ischemia of at least 10%. Again, these are lower rates than would be expected based on historical data taken from the era before aggressive risk factor modification in patients with diabetes and CAD symptoms.

During a median 2.4 years of follow-up, the combined rate of cardiovascular death, nonfatal MI, or revascularization more than 4 weeks after myocardial perfusion imaging was 32% in patients with at least 10% left ventricular ischemia on their presenting SPECT study, 14% in those with 1%-9% ischemia, and 8% in those with no ischemia.

Patients who achieved at least 10 METs (metabolic equivalents) on the treadmill during testing had the best prognosis. The sole event that occurred in this subgroup was a late revascularization.

In all, 60% of hard cardiac events occurring in this study were in patients with no perfusion defects. This points to the need for improved patient selection and risk stratification techniques in diabetes patients, according to Dr. Bourque.

Major Finding: The annual combined rate of cardiovascular death or nonfatal MI was 2.4% in a prospective series of diabetes patients with stable symptoms suggestive of CAD.

Data Source: A consecutive series of 444 patients followed for a median of 2.4 years.

Disclosures: Dr. Bourque said he had no financial conflicts.

DENVER – Diabetes patients with stable symptoms of coronary artery disease appear to have a lower cardiac event risk than previously thought.

The yearly rate of cardiovascular death or nonfatal MI was just 2.4% in a series of 444 consecutive diabetes outpatients with symptoms suggestive of coronary artery disease (CAD) who underwent exercise treadmill or pharmacologic stress single-photon emission computed tomography (SPECT) myocardial perfusion imaging. The cardiovascular death rate of 0.4% per year and the nonfatal MI rate of 2.0% per year were surprisingly low, given that 39% of subjects had known CAD and the rest had symptoms suggestive of CAD, Dr. Jamieson M. Bourque noted at the meeting.

The explanation may be found at least in part in contemporary evidence-based intensive medical management for risk reduction in this traditionally high-risk population, added Dr. Bourque of the University of Virginia, Charlottesville.

Of the 444 symptomatic diabetes patients, 78.5% had no inducible ischemia on stress SPECT myocardial perfusion imaging, 16.5% had 1%-9% left ventricular ischemia, and 5% had left ventricular ischemia of at least 10%. Again, these are lower rates than would be expected based on historical data taken from the era before aggressive risk factor modification in patients with diabetes and CAD symptoms.

During a median 2.4 years of follow-up, the combined rate of cardiovascular death, nonfatal MI, or revascularization more than 4 weeks after myocardial perfusion imaging was 32% in patients with at least 10% left ventricular ischemia on their presenting SPECT study, 14% in those with 1%-9% ischemia, and 8% in those with no ischemia.

Patients who achieved at least 10 METs (metabolic equivalents) on the treadmill during testing had the best prognosis. The sole event that occurred in this subgroup was a late revascularization.

In all, 60% of hard cardiac events occurring in this study were in patients with no perfusion defects. This points to the need for improved patient selection and risk stratification techniques in diabetes patients, according to Dr. Bourque.

Major Finding: The annual combined rate of cardiovascular death or nonfatal MI was 2.4% in a prospective series of diabetes patients with stable symptoms suggestive of CAD.

Data Source: A consecutive series of 444 patients followed for a median of 2.4 years.

Disclosures: Dr. Bourque said he had no financial conflicts.

DENVER – Diabetes patients with stable symptoms of coronary artery disease appear to have a lower cardiac event risk than previously thought.

The yearly rate of cardiovascular death or nonfatal MI was just 2.4% in a series of 444 consecutive diabetes outpatients with symptoms suggestive of coronary artery disease (CAD) who underwent exercise treadmill or pharmacologic stress single-photon emission computed tomography (SPECT) myocardial perfusion imaging. The cardiovascular death rate of 0.4% per year and the nonfatal MI rate of 2.0% per year were surprisingly low, given that 39% of subjects had known CAD and the rest had symptoms suggestive of CAD, Dr. Jamieson M. Bourque noted at the meeting.

The explanation may be found at least in part in contemporary evidence-based intensive medical management for risk reduction in this traditionally high-risk population, added Dr. Bourque of the University of Virginia, Charlottesville.

Of the 444 symptomatic diabetes patients, 78.5% had no inducible ischemia on stress SPECT myocardial perfusion imaging, 16.5% had 1%-9% left ventricular ischemia, and 5% had left ventricular ischemia of at least 10%. Again, these are lower rates than would be expected based on historical data taken from the era before aggressive risk factor modification in patients with diabetes and CAD symptoms.

During a median 2.4 years of follow-up, the combined rate of cardiovascular death, nonfatal MI, or revascularization more than 4 weeks after myocardial perfusion imaging was 32% in patients with at least 10% left ventricular ischemia on their presenting SPECT study, 14% in those with 1%-9% ischemia, and 8% in those with no ischemia.

Patients who achieved at least 10 METs (metabolic equivalents) on the treadmill during testing had the best prognosis. The sole event that occurred in this subgroup was a late revascularization.

In all, 60% of hard cardiac events occurring in this study were in patients with no perfusion defects. This points to the need for improved patient selection and risk stratification techniques in diabetes patients, according to Dr. Bourque.

BOULDER, COLO. – A buzz of excitement – a sense of history in the making – was palpable as the newly incorporated Society of Ob/Gyn Hospitalists held its first-ever annual meeting here.

“We are all witnessing the birth of a new subspecialty,” declared Dr. Brigid McCue, an ob.gyn. hospitalist at Jordan Hospital in Plymouth, Mass., and a member of the Society of Ob/Gyn Hospitalists (SOGH) steering committee.

Present at the birth were officials from both the American College of Obstetricians and Gynecologists (ACOG) and the Society of Hospital Medicine (SHM), two organizations interested in having close ties with the new medical society.

“ACOG recognizes this is the new paradigm of care,” said Dr. J. Joshua Kopelman, chair of ACOG District VIII. “We absolutely want you to be people who provide input about what you do to all of the committees at the executive level of the college.”

“Ob.gyn. hospitalists in this country are the wave of the future. There's no question about it. The model has been going on for a long time in Great Britain, for example, where you have people whose practices are office-based, and you have people who work full time in the hospital and that's all they do. They've had to learn how to do patient handoffs between these two groups of physicians,” he added.

Dr. Shaun Frost, president-elect of the SHM, observed that “it's kind of mind-boggling” to see the parallels between the birth of that organization and the SOGH. Both groups began with a small cadre of enthusiastic people full of outside-the-box ideas about how to improve patient care in the hospital.

Hospital medicine has experienced astronomical growth. The SHM consisted of 23 members in 1997, the year of its birth. Membership climbed to 800 just 2 years later, then to 3,200 in 2003, 6,300 in 2006, and now sits at about 12,000.

“I would anticipate that you're going to experience the same thing we did in terms of rapid and significant growth. Tighten your seat belts – it can be a wild ride sometimes, but I can tell you that for me, after 14 years, it has been nothing short of profoundly gratifying,” said Dr. Frost, who is chief medical officer for the Northeast region of Cogent HMG Healthcare and an internist at the University of Minnesota, Minneapolis.

In an interview, meeting cochair Dr. Rob Olson said at present there are 143 ob.gyn. hospitalist groups spread throughout the country, typically with four to six hospitalists each. Most work 12-hour shifts, some 24-hour shifts.

“Right now hospitalists are doing a very small percentage of all deliveries, maybe 2%. I project in 5 years we'll be doing 20% or 25%,” predicted Dr. Olson, an ob.gyn. hospitalist in Bellingham, Wash., and founder of www.obgynhospitalist.com

The primary mission of ob.gyn. hospitalists is to enhance patient safety in the hospital, he explained. If an emergency requiring cesarean section occurs, the hospitalist can start the operation while the private obstetrician is en route, shifting to second assistant when the private physician arrives and takes over the procedure. Or if a woman who has been in labor for a few hours begins progressing rapidly at 2 a.m., the hospitalist can step in and do the delivery if the private physician can't get to the hospital promptly.

Hospitalists can also provide support when a midwife or family physician has a complicated delivery requiring a vacuum extraction, forceps, or a cesarean section.

“It's kind of like being a lifeguard, where you're sitting at the beach waiting for the problem,” he said.

Ordinarily a hospitalist will never see a patient antepartum. The exception is the unassigned patient who may drop in to the hospital with no prenatal care, who then becomes the hospitalist's responsibility.

Hospitalists also support private physicians by letting them sign out patients as a convenience. “A private physician may say, 'I've got a big surgery tomorrow. Can you take care of all of my patients between midnight and 6 a.m. so I can sleep?' That's another way of utilizing us,” Dr. Olson continued.

In the initial months following introduction of an ob.gyn. hospitalist program, however, patient sign-outs typically aren't a substantial part of the job. “At the beginning the private doctors are a little worried about it. They don't want to sign out. They're suspicious. They're afraid that they're going to give up not only their patients but their revenue. When they realize how helpful check outs are, though, then they sign out,” he explained.

Some ob.gyn. hospitalists are laborists only and prefer it that way. Others also cover gynecologic cases in the emergency department. “I have diagnosed more horrific cancers in 18 months as a hospitalist than in 13 years of private practice,” Dr. McCue said, adding that she feels good about covering gynecologic cases in the ER because it enables her to maintain some of her hard-earned gynecologic skills.

Several audience members voiced discomfort about leaving the labor and delivery area to take on emergency department gynecologic surgical cases because it distracts from the primary hospitalist focus of saving babies. Dr. McCue responded that the answer is to negotiate boundaries.

“What most of the hospitalist programs are coming to is making a deal with the privates,” she explained. “You say, 'I am doing the vast majority of your nighttime work by covering the labor floor for you and covering the first calls for you. All that I ask is that you be available on an emergency basis for the ER overload that I can't handle. I am happy to get the ectopics and incompletes started for you, but if I call that's because I need you to be there to cover.'”

Conference attendees heard best-practice updates from authorities on obstetric triage and evidence-based cesarean section techniques. They also began planning SOGH's future course. Dr. Bob Fagnant circulated a rough draft of proposed core competencies defining what ob.gyn. hospitalists need to be able to do. (See box.)

The society will eventually have to formally settle on a group of core competencies, a program for attaining them, and a means of tracking them to attain subspecialty status from the American Board of Obstetrics and Gynecology. The board will want to see evidence that being an ob.gyn. hospitalist requires a special set of skills not taught to physicians who graduate residency as general ob.gyns., explained Dr. Fagnant, an ob.gyn. hospitalist at Intermountain Health Care in St. George, Utah, who is also vice chair of the ACOG Committee on Ambulatory Practice.

The SOGH leadership believes simulation training will play a key role in demonstrating ob.gyn. hospitalist competencies. Toward that end, SOGH's first annual meeting featured a half-day of participation in a three-station obstetrical emergency simulation workshop focused on management of obstetric hemorrhage, maneuvers and techniques to relieve shoulder dystocia, and operative deliveries.

Dr. Arthur Townsend, medical director of the ob.gyn. hospitalist program at Methodist Le-Bonheur Hospital in Germantown, Tenn., stressed that hospitalists are “perfectly positioned” to support the quality initiatives hospitals take on to improve outcomes, decrease liability, attract patients, and meet the requirements of outside national organizations that report on quality indicators, such as the National Perinatal Information Center/Quality Analytic Services.

A significant part of what he and his hospitalist colleagues do is gather statistics. These include hospital-wide cesarean rates, vaginal births after cesarean, incidence of episiotomy, third- and fourth-degree laceration rates, postpartum hemorrhage, vaginal deliveries with shoulder dystocia, and a host of others.

He and his fellow hospitalists also carefully track their own performance. They file a detailed online report at a secure website upon completing every shift. These shift reports are compiled into monthly reports totaling the number of deliveries the hospitalists have performed, assists provided at cesarean and vaginal deliveries, the emergencies hospitalists responded to, the number of gynecologic surgeries performed, unassigned patients they've seen, and nurse and physician satisfaction survey results. These reports go to the hospital CEO, the board of directors, and the hospital risk management and quality committees.

“We've got some data to show that we really make a difference. What we do in these reports is tell how we save people. Everyone wants to know how many patients we're saving,” he explained.

The hospitalists track and submit individual physician-level statistics. When the data point to a problem physician – for example, an ob.gyn. who doesn't return phone calls from a nighttime nurse in timely fashion or who regularly scores poorly in patient satisfaction – Dr. Townsend leaves it to the hospital quality committee to do something about it. “I don't want to be the sheriff,” he explained.

These data-filled reports document the progress the hospital has made in achieving safety. This in turn has led to a reduction in the cost of the hospital's risk insurance. Moreover, when Dr. Townsend made a presentation to the hospital's risk underwriter, the company was so favorably impressed by what ob.gyn. hospitalists do that it provided them with a $60,000 grant to purchase obstetrical emergency simulators.

Dr. Townsend asked audience members to think about which hospitalist quality measures they consider to be most important yet practical for hospitalist practices to routinely collect at the national level. This is an issue where SOGH would like to be able to provide recommendations.

Dr. Suneet P. Chauhan, a non-hospitalist guest speaker at the conference, recommended focusing initially on two key statistics where he believes ob.gyn. hospitalists could make an impact with maximum “wow” factor: time to cesarean section for nonreassuring fetal heart rate tracings, and time spent in obstetric triage for preterm labor.

“As everyone knows, in one-third of cases the decision-to-incision time in an emergency c-section is not met. The lawyers know that, too. You, more than any other person in the hospital, can decrease the decision-to-incision time,” he told the hospitalists.

“You can also really help in obstetric triage. Triage is a very expensive place. In our hospital a patient could be there 3-6 hours before being seen. But if hospitalists routinely adopted the use of transvaginal cervical length measurement and/or fetal fibronectin, it would really shorten the stay at triage,” predicted Dr. Chauhan, director of maternal-fetal medicine and professor of ob.gyn. at Eastern Virginia Medical School, Norfolk.

Dr. Frost, the SHM president-elect, shared five key lessons he believes to be essential in building a hospitalist medical society from scratch, based upon the SHM experience: focus keenly on quality improvement; seek to be recognized by external stakeholders as health care reform facilitators, not obstructionists; respect the power of 'branding” as hospitalists; define your members' uniqueness; and be an inclusive “big tent” organization rather than exclusive in terms of membership.

ACOG District VIII Chair Dr. Kopelman urged SOGH members to make their viewpoint heard at ACOG by becoming active at the section and district level, then applying for one of the roughly 50 new committee appointments made each year. Natural fits for SOGH members might be the Committee on Patient Safety and Quality Improvement, the Committee on Obstetric Practice, the Committee on Professional Liability, and the Council on Resident Education in Obstetrics and Gynecology. He also urged SOGH leaders to enroll in ACOG's Robert C. Cefalo National Leadership Institute.

SOGH leaders urged their members to seriously consider belonging to both ACOG and SHM, two organizations having the ear of health policy makers.

Dr. Rob Olson said at present there are 143 ob.gyn. hospitalist groups spread throughout the country, typically with four to six hospitalists each.

Source Courtesy Ianthe Andress

'It can be a wild ride sometimes, but … it has been nothing short of profoundly gratifying.'

Source DR. FROST

Rough Draft of Core Competencies

Obstetric triage

Emergency medical examination

Outpatient prenatal care

Management of labor

Fetal heart rate interpretation

Labor ultrasound

Vaginal delivery and laceration repair

Management of obstetric complications including eclampsia, shoulder dystocia, breech presentation, twins, and postpartum hemorrhage

Operative deliveries

Surgical skills entailed in tubal ligation, cesarean section, and immediate postpartum hemorrhage

Gynecologic competencies including deep vein thrombosis prevention, diagnosis, and management; the gynecologic examination including the pelvic exam; and postoperative hemorrhage management.

Source: SOGH

BOULDER, COLO. – A buzz of excitement – a sense of history in the making – was palpable as the newly incorporated Society of Ob/Gyn Hospitalists held its first-ever annual meeting here.

“We are all witnessing the birth of a new subspecialty,” declared Dr. Brigid McCue, an ob.gyn. hospitalist at Jordan Hospital in Plymouth, Mass., and a member of the Society of Ob/Gyn Hospitalists (SOGH) steering committee.

Present at the birth were officials from both the American College of Obstetricians and Gynecologists (ACOG) and the Society of Hospital Medicine (SHM), two organizations interested in having close ties with the new medical society.

“ACOG recognizes this is the new paradigm of care,” said Dr. J. Joshua Kopelman, chair of ACOG District VIII. “We absolutely want you to be people who provide input about what you do to all of the committees at the executive level of the college.”

“Ob.gyn. hospitalists in this country are the wave of the future. There's no question about it. The model has been going on for a long time in Great Britain, for example, where you have people whose practices are office-based, and you have people who work full time in the hospital and that's all they do. They've had to learn how to do patient handoffs between these two groups of physicians,” he added.

Dr. Shaun Frost, president-elect of the SHM, observed that “it's kind of mind-boggling” to see the parallels between the birth of that organization and the SOGH. Both groups began with a small cadre of enthusiastic people full of outside-the-box ideas about how to improve patient care in the hospital.

Hospital medicine has experienced astronomical growth. The SHM consisted of 23 members in 1997, the year of its birth. Membership climbed to 800 just 2 years later, then to 3,200 in 2003, 6,300 in 2006, and now sits at about 12,000.

“I would anticipate that you're going to experience the same thing we did in terms of rapid and significant growth. Tighten your seat belts – it can be a wild ride sometimes, but I can tell you that for me, after 14 years, it has been nothing short of profoundly gratifying,” said Dr. Frost, who is chief medical officer for the Northeast region of Cogent HMG Healthcare and an internist at the University of Minnesota, Minneapolis.

In an interview, meeting cochair Dr. Rob Olson said at present there are 143 ob.gyn. hospitalist groups spread throughout the country, typically with four to six hospitalists each. Most work 12-hour shifts, some 24-hour shifts.

“Right now hospitalists are doing a very small percentage of all deliveries, maybe 2%. I project in 5 years we'll be doing 20% or 25%,” predicted Dr. Olson, an ob.gyn. hospitalist in Bellingham, Wash., and founder of www.obgynhospitalist.com

The primary mission of ob.gyn. hospitalists is to enhance patient safety in the hospital, he explained. If an emergency requiring cesarean section occurs, the hospitalist can start the operation while the private obstetrician is en route, shifting to second assistant when the private physician arrives and takes over the procedure. Or if a woman who has been in labor for a few hours begins progressing rapidly at 2 a.m., the hospitalist can step in and do the delivery if the private physician can't get to the hospital promptly.

Hospitalists can also provide support when a midwife or family physician has a complicated delivery requiring a vacuum extraction, forceps, or a cesarean section.

“It's kind of like being a lifeguard, where you're sitting at the beach waiting for the problem,” he said.

Ordinarily a hospitalist will never see a patient antepartum. The exception is the unassigned patient who may drop in to the hospital with no prenatal care, who then becomes the hospitalist's responsibility.

Hospitalists also support private physicians by letting them sign out patients as a convenience. “A private physician may say, 'I've got a big surgery tomorrow. Can you take care of all of my patients between midnight and 6 a.m. so I can sleep?' That's another way of utilizing us,” Dr. Olson continued.

In the initial months following introduction of an ob.gyn. hospitalist program, however, patient sign-outs typically aren't a substantial part of the job. “At the beginning the private doctors are a little worried about it. They don't want to sign out. They're suspicious. They're afraid that they're going to give up not only their patients but their revenue. When they realize how helpful check outs are, though, then they sign out,” he explained.

Some ob.gyn. hospitalists are laborists only and prefer it that way. Others also cover gynecologic cases in the emergency department. “I have diagnosed more horrific cancers in 18 months as a hospitalist than in 13 years of private practice,” Dr. McCue said, adding that she feels good about covering gynecologic cases in the ER because it enables her to maintain some of her hard-earned gynecologic skills.

Several audience members voiced discomfort about leaving the labor and delivery area to take on emergency department gynecologic surgical cases because it distracts from the primary hospitalist focus of saving babies. Dr. McCue responded that the answer is to negotiate boundaries.

“What most of the hospitalist programs are coming to is making a deal with the privates,” she explained. “You say, 'I am doing the vast majority of your nighttime work by covering the labor floor for you and covering the first calls for you. All that I ask is that you be available on an emergency basis for the ER overload that I can't handle. I am happy to get the ectopics and incompletes started for you, but if I call that's because I need you to be there to cover.'”

Conference attendees heard best-practice updates from authorities on obstetric triage and evidence-based cesarean section techniques. They also began planning SOGH's future course. Dr. Bob Fagnant circulated a rough draft of proposed core competencies defining what ob.gyn. hospitalists need to be able to do. (See box.)

The society will eventually have to formally settle on a group of core competencies, a program for attaining them, and a means of tracking them to attain subspecialty status from the American Board of Obstetrics and Gynecology. The board will want to see evidence that being an ob.gyn. hospitalist requires a special set of skills not taught to physicians who graduate residency as general ob.gyns., explained Dr. Fagnant, an ob.gyn. hospitalist at Intermountain Health Care in St. George, Utah, who is also vice chair of the ACOG Committee on Ambulatory Practice.

The SOGH leadership believes simulation training will play a key role in demonstrating ob.gyn. hospitalist competencies. Toward that end, SOGH's first annual meeting featured a half-day of participation in a three-station obstetrical emergency simulation workshop focused on management of obstetric hemorrhage, maneuvers and techniques to relieve shoulder dystocia, and operative deliveries.

Dr. Arthur Townsend, medical director of the ob.gyn. hospitalist program at Methodist Le-Bonheur Hospital in Germantown, Tenn., stressed that hospitalists are “perfectly positioned” to support the quality initiatives hospitals take on to improve outcomes, decrease liability, attract patients, and meet the requirements of outside national organizations that report on quality indicators, such as the National Perinatal Information Center/Quality Analytic Services.

A significant part of what he and his hospitalist colleagues do is gather statistics. These include hospital-wide cesarean rates, vaginal births after cesarean, incidence of episiotomy, third- and fourth-degree laceration rates, postpartum hemorrhage, vaginal deliveries with shoulder dystocia, and a host of others.

He and his fellow hospitalists also carefully track their own performance. They file a detailed online report at a secure website upon completing every shift. These shift reports are compiled into monthly reports totaling the number of deliveries the hospitalists have performed, assists provided at cesarean and vaginal deliveries, the emergencies hospitalists responded to, the number of gynecologic surgeries performed, unassigned patients they've seen, and nurse and physician satisfaction survey results. These reports go to the hospital CEO, the board of directors, and the hospital risk management and quality committees.

“We've got some data to show that we really make a difference. What we do in these reports is tell how we save people. Everyone wants to know how many patients we're saving,” he explained.

The hospitalists track and submit individual physician-level statistics. When the data point to a problem physician – for example, an ob.gyn. who doesn't return phone calls from a nighttime nurse in timely fashion or who regularly scores poorly in patient satisfaction – Dr. Townsend leaves it to the hospital quality committee to do something about it. “I don't want to be the sheriff,” he explained.

These data-filled reports document the progress the hospital has made in achieving safety. This in turn has led to a reduction in the cost of the hospital's risk insurance. Moreover, when Dr. Townsend made a presentation to the hospital's risk underwriter, the company was so favorably impressed by what ob.gyn. hospitalists do that it provided them with a $60,000 grant to purchase obstetrical emergency simulators.

Dr. Townsend asked audience members to think about which hospitalist quality measures they consider to be most important yet practical for hospitalist practices to routinely collect at the national level. This is an issue where SOGH would like to be able to provide recommendations.

Dr. Suneet P. Chauhan, a non-hospitalist guest speaker at the conference, recommended focusing initially on two key statistics where he believes ob.gyn. hospitalists could make an impact with maximum “wow” factor: time to cesarean section for nonreassuring fetal heart rate tracings, and time spent in obstetric triage for preterm labor.

“As everyone knows, in one-third of cases the decision-to-incision time in an emergency c-section is not met. The lawyers know that, too. You, more than any other person in the hospital, can decrease the decision-to-incision time,” he told the hospitalists.

“You can also really help in obstetric triage. Triage is a very expensive place. In our hospital a patient could be there 3-6 hours before being seen. But if hospitalists routinely adopted the use of transvaginal cervical length measurement and/or fetal fibronectin, it would really shorten the stay at triage,” predicted Dr. Chauhan, director of maternal-fetal medicine and professor of ob.gyn. at Eastern Virginia Medical School, Norfolk.

Dr. Frost, the SHM president-elect, shared five key lessons he believes to be essential in building a hospitalist medical society from scratch, based upon the SHM experience: focus keenly on quality improvement; seek to be recognized by external stakeholders as health care reform facilitators, not obstructionists; respect the power of 'branding” as hospitalists; define your members' uniqueness; and be an inclusive “big tent” organization rather than exclusive in terms of membership.

ACOG District VIII Chair Dr. Kopelman urged SOGH members to make their viewpoint heard at ACOG by becoming active at the section and district level, then applying for one of the roughly 50 new committee appointments made each year. Natural fits for SOGH members might be the Committee on Patient Safety and Quality Improvement, the Committee on Obstetric Practice, the Committee on Professional Liability, and the Council on Resident Education in Obstetrics and Gynecology. He also urged SOGH leaders to enroll in ACOG's Robert C. Cefalo National Leadership Institute.

SOGH leaders urged their members to seriously consider belonging to both ACOG and SHM, two organizations having the ear of health policy makers.

Dr. Rob Olson said at present there are 143 ob.gyn. hospitalist groups spread throughout the country, typically with four to six hospitalists each.

Source Courtesy Ianthe Andress

'It can be a wild ride sometimes, but … it has been nothing short of profoundly gratifying.'

Source DR. FROST

Rough Draft of Core Competencies

Obstetric triage

Emergency medical examination

Outpatient prenatal care

Management of labor

Fetal heart rate interpretation

Labor ultrasound

Vaginal delivery and laceration repair

Management of obstetric complications including eclampsia, shoulder dystocia, breech presentation, twins, and postpartum hemorrhage

Operative deliveries

Surgical skills entailed in tubal ligation, cesarean section, and immediate postpartum hemorrhage

Gynecologic competencies including deep vein thrombosis prevention, diagnosis, and management; the gynecologic examination including the pelvic exam; and postoperative hemorrhage management.

Source: SOGH

BOULDER, COLO. – A buzz of excitement – a sense of history in the making – was palpable as the newly incorporated Society of Ob/Gyn Hospitalists held its first-ever annual meeting here.

“We are all witnessing the birth of a new subspecialty,” declared Dr. Brigid McCue, an ob.gyn. hospitalist at Jordan Hospital in Plymouth, Mass., and a member of the Society of Ob/Gyn Hospitalists (SOGH) steering committee.

Present at the birth were officials from both the American College of Obstetricians and Gynecologists (ACOG) and the Society of Hospital Medicine (SHM), two organizations interested in having close ties with the new medical society.

“ACOG recognizes this is the new paradigm of care,” said Dr. J. Joshua Kopelman, chair of ACOG District VIII. “We absolutely want you to be people who provide input about what you do to all of the committees at the executive level of the college.”

“Ob.gyn. hospitalists in this country are the wave of the future. There's no question about it. The model has been going on for a long time in Great Britain, for example, where you have people whose practices are office-based, and you have people who work full time in the hospital and that's all they do. They've had to learn how to do patient handoffs between these two groups of physicians,” he added.

Dr. Shaun Frost, president-elect of the SHM, observed that “it's kind of mind-boggling” to see the parallels between the birth of that organization and the SOGH. Both groups began with a small cadre of enthusiastic people full of outside-the-box ideas about how to improve patient care in the hospital.

Hospital medicine has experienced astronomical growth. The SHM consisted of 23 members in 1997, the year of its birth. Membership climbed to 800 just 2 years later, then to 3,200 in 2003, 6,300 in 2006, and now sits at about 12,000.

“I would anticipate that you're going to experience the same thing we did in terms of rapid and significant growth. Tighten your seat belts – it can be a wild ride sometimes, but I can tell you that for me, after 14 years, it has been nothing short of profoundly gratifying,” said Dr. Frost, who is chief medical officer for the Northeast region of Cogent HMG Healthcare and an internist at the University of Minnesota, Minneapolis.

In an interview, meeting cochair Dr. Rob Olson said at present there are 143 ob.gyn. hospitalist groups spread throughout the country, typically with four to six hospitalists each. Most work 12-hour shifts, some 24-hour shifts.

“Right now hospitalists are doing a very small percentage of all deliveries, maybe 2%. I project in 5 years we'll be doing 20% or 25%,” predicted Dr. Olson, an ob.gyn. hospitalist in Bellingham, Wash., and founder of www.obgynhospitalist.com

The primary mission of ob.gyn. hospitalists is to enhance patient safety in the hospital, he explained. If an emergency requiring cesarean section occurs, the hospitalist can start the operation while the private obstetrician is en route, shifting to second assistant when the private physician arrives and takes over the procedure. Or if a woman who has been in labor for a few hours begins progressing rapidly at 2 a.m., the hospitalist can step in and do the delivery if the private physician can't get to the hospital promptly.

Hospitalists can also provide support when a midwife or family physician has a complicated delivery requiring a vacuum extraction, forceps, or a cesarean section.

“It's kind of like being a lifeguard, where you're sitting at the beach waiting for the problem,” he said.

Ordinarily a hospitalist will never see a patient antepartum. The exception is the unassigned patient who may drop in to the hospital with no prenatal care, who then becomes the hospitalist's responsibility.

Hospitalists also support private physicians by letting them sign out patients as a convenience. “A private physician may say, 'I've got a big surgery tomorrow. Can you take care of all of my patients between midnight and 6 a.m. so I can sleep?' That's another way of utilizing us,” Dr. Olson continued.

In the initial months following introduction of an ob.gyn. hospitalist program, however, patient sign-outs typically aren't a substantial part of the job. “At the beginning the private doctors are a little worried about it. They don't want to sign out. They're suspicious. They're afraid that they're going to give up not only their patients but their revenue. When they realize how helpful check outs are, though, then they sign out,” he explained.

Some ob.gyn. hospitalists are laborists only and prefer it that way. Others also cover gynecologic cases in the emergency department. “I have diagnosed more horrific cancers in 18 months as a hospitalist than in 13 years of private practice,” Dr. McCue said, adding that she feels good about covering gynecologic cases in the ER because it enables her to maintain some of her hard-earned gynecologic skills.

Several audience members voiced discomfort about leaving the labor and delivery area to take on emergency department gynecologic surgical cases because it distracts from the primary hospitalist focus of saving babies. Dr. McCue responded that the answer is to negotiate boundaries.

“What most of the hospitalist programs are coming to is making a deal with the privates,” she explained. “You say, 'I am doing the vast majority of your nighttime work by covering the labor floor for you and covering the first calls for you. All that I ask is that you be available on an emergency basis for the ER overload that I can't handle. I am happy to get the ectopics and incompletes started for you, but if I call that's because I need you to be there to cover.'”

Conference attendees heard best-practice updates from authorities on obstetric triage and evidence-based cesarean section techniques. They also began planning SOGH's future course. Dr. Bob Fagnant circulated a rough draft of proposed core competencies defining what ob.gyn. hospitalists need to be able to do. (See box.)

The society will eventually have to formally settle on a group of core competencies, a program for attaining them, and a means of tracking them to attain subspecialty status from the American Board of Obstetrics and Gynecology. The board will want to see evidence that being an ob.gyn. hospitalist requires a special set of skills not taught to physicians who graduate residency as general ob.gyns., explained Dr. Fagnant, an ob.gyn. hospitalist at Intermountain Health Care in St. George, Utah, who is also vice chair of the ACOG Committee on Ambulatory Practice.

The SOGH leadership believes simulation training will play a key role in demonstrating ob.gyn. hospitalist competencies. Toward that end, SOGH's first annual meeting featured a half-day of participation in a three-station obstetrical emergency simulation workshop focused on management of obstetric hemorrhage, maneuvers and techniques to relieve shoulder dystocia, and operative deliveries.

Dr. Arthur Townsend, medical director of the ob.gyn. hospitalist program at Methodist Le-Bonheur Hospital in Germantown, Tenn., stressed that hospitalists are “perfectly positioned” to support the quality initiatives hospitals take on to improve outcomes, decrease liability, attract patients, and meet the requirements of outside national organizations that report on quality indicators, such as the National Perinatal Information Center/Quality Analytic Services.

A significant part of what he and his hospitalist colleagues do is gather statistics. These include hospital-wide cesarean rates, vaginal births after cesarean, incidence of episiotomy, third- and fourth-degree laceration rates, postpartum hemorrhage, vaginal deliveries with shoulder dystocia, and a host of others.

He and his fellow hospitalists also carefully track their own performance. They file a detailed online report at a secure website upon completing every shift. These shift reports are compiled into monthly reports totaling the number of deliveries the hospitalists have performed, assists provided at cesarean and vaginal deliveries, the emergencies hospitalists responded to, the number of gynecologic surgeries performed, unassigned patients they've seen, and nurse and physician satisfaction survey results. These reports go to the hospital CEO, the board of directors, and the hospital risk management and quality committees.

“We've got some data to show that we really make a difference. What we do in these reports is tell how we save people. Everyone wants to know how many patients we're saving,” he explained.

The hospitalists track and submit individual physician-level statistics. When the data point to a problem physician – for example, an ob.gyn. who doesn't return phone calls from a nighttime nurse in timely fashion or who regularly scores poorly in patient satisfaction – Dr. Townsend leaves it to the hospital quality committee to do something about it. “I don't want to be the sheriff,” he explained.

These data-filled reports document the progress the hospital has made in achieving safety. This in turn has led to a reduction in the cost of the hospital's risk insurance. Moreover, when Dr. Townsend made a presentation to the hospital's risk underwriter, the company was so favorably impressed by what ob.gyn. hospitalists do that it provided them with a $60,000 grant to purchase obstetrical emergency simulators.

Dr. Townsend asked audience members to think about which hospitalist quality measures they consider to be most important yet practical for hospitalist practices to routinely collect at the national level. This is an issue where SOGH would like to be able to provide recommendations.

Dr. Suneet P. Chauhan, a non-hospitalist guest speaker at the conference, recommended focusing initially on two key statistics where he believes ob.gyn. hospitalists could make an impact with maximum “wow” factor: time to cesarean section for nonreassuring fetal heart rate tracings, and time spent in obstetric triage for preterm labor.

“As everyone knows, in one-third of cases the decision-to-incision time in an emergency c-section is not met. The lawyers know that, too. You, more than any other person in the hospital, can decrease the decision-to-incision time,” he told the hospitalists.

“You can also really help in obstetric triage. Triage is a very expensive place. In our hospital a patient could be there 3-6 hours before being seen. But if hospitalists routinely adopted the use of transvaginal cervical length measurement and/or fetal fibronectin, it would really shorten the stay at triage,” predicted Dr. Chauhan, director of maternal-fetal medicine and professor of ob.gyn. at Eastern Virginia Medical School, Norfolk.

Dr. Frost, the SHM president-elect, shared five key lessons he believes to be essential in building a hospitalist medical society from scratch, based upon the SHM experience: focus keenly on quality improvement; seek to be recognized by external stakeholders as health care reform facilitators, not obstructionists; respect the power of 'branding” as hospitalists; define your members' uniqueness; and be an inclusive “big tent” organization rather than exclusive in terms of membership.

ACOG District VIII Chair Dr. Kopelman urged SOGH members to make their viewpoint heard at ACOG by becoming active at the section and district level, then applying for one of the roughly 50 new committee appointments made each year. Natural fits for SOGH members might be the Committee on Patient Safety and Quality Improvement, the Committee on Obstetric Practice, the Committee on Professional Liability, and the Council on Resident Education in Obstetrics and Gynecology. He also urged SOGH leaders to enroll in ACOG's Robert C. Cefalo National Leadership Institute.

SOGH leaders urged their members to seriously consider belonging to both ACOG and SHM, two organizations having the ear of health policy makers.

Dr. Rob Olson said at present there are 143 ob.gyn. hospitalist groups spread throughout the country, typically with four to six hospitalists each.

Source Courtesy Ianthe Andress

'It can be a wild ride sometimes, but … it has been nothing short of profoundly gratifying.'

Source DR. FROST

Rough Draft of Core Competencies

Obstetric triage

Emergency medical examination

Outpatient prenatal care

Management of labor

Fetal heart rate interpretation

Labor ultrasound

Vaginal delivery and laceration repair

Management of obstetric complications including eclampsia, shoulder dystocia, breech presentation, twins, and postpartum hemorrhage

Operative deliveries

Surgical skills entailed in tubal ligation, cesarean section, and immediate postpartum hemorrhage

Gynecologic competencies including deep vein thrombosis prevention, diagnosis, and management; the gynecologic examination including the pelvic exam; and postoperative hemorrhage management.

Source: SOGH

LISBON – Nearly 30% of patients diagnosed with a first pathologically confirmed basal cell carcinoma will develop one or more additional primary basal cell carcinomas within 5 years.

This finding, from a comprehensive Dutch national cancer registry, has important implications for clinical practice, noted Dr. Sophie C. Flohil at the annual congress of the European Academy of Dermatology and Venereology.

Courtesy Dr. Amit G. Pandya

"Based upon our results, we would like to recommend that all BCC [basal cell carcinoma] patients undergo annual follow-up visits with full-body skin examinations for at least 3 years after their first BCC diagnosis."

She presented a cohort study involving 2,483 consecutive unselected Dutch patients diagnosed with a first histological confirmed BCC during 2004.

During 5 years of prospective follow-up in PALGA, the Dutch nationwide network and registry of histo- and cytopathology, 29.2% of the patients were diagnosed with one or more additional primary BCCs, according to Dr. Flohil, a dermatology resident at Erasmus University, Rotterdam, the Netherlands.

More than one-third of patients who developed a second primary BCC within 5 years did so during the first 6 months after diagnosis of the first.

The cumulative risk during the first 6 months of follow-up was extraordinarily high at 11.2%, as compared with 13.9% through 1 year, 18.5% after 2 years, 22.1% at 3 years, 25.5% after 4 years, and 29.2% after 5 years, she said. This translates into an incidence rate of 25,318 cases per 100,000 person-years during the first half-year after diagnosis of a first primary tumor.

"We think that this could indicate that these second BCCs that occur in the first 6 months after a first BCC diagnosis were already present at the date of the first BCC diagnosis, but were somehow missed then by the dermatologist or the doctor they went to," she said.

Still, the incidence rate remained quite high during the first several years of follow-up: 15,737 cases per 100,000 person-years through the first year and 10,779 per 100,000 person-years after 2 years before tailing off to 8,752 per 100,000 person-years at 3 years.

In a multivariate analysis, men had an adjusted 30% increased risk of developing one or more subsequent BCCs, and patients aged 65-79 years had an 81% greater risk than those under age 50.

Dr. Flohil declared having no financial conflicts of interest.

LISBON – Nearly 30% of patients diagnosed with a first pathologically confirmed basal cell carcinoma will develop one or more additional primary basal cell carcinomas within 5 years.

This finding, from a comprehensive Dutch national cancer registry, has important implications for clinical practice, noted Dr. Sophie C. Flohil at the annual congress of the European Academy of Dermatology and Venereology.

Courtesy Dr. Amit G. Pandya

"Based upon our results, we would like to recommend that all BCC [basal cell carcinoma] patients undergo annual follow-up visits with full-body skin examinations for at least 3 years after their first BCC diagnosis."

She presented a cohort study involving 2,483 consecutive unselected Dutch patients diagnosed with a first histological confirmed BCC during 2004.

During 5 years of prospective follow-up in PALGA, the Dutch nationwide network and registry of histo- and cytopathology, 29.2% of the patients were diagnosed with one or more additional primary BCCs, according to Dr. Flohil, a dermatology resident at Erasmus University, Rotterdam, the Netherlands.

More than one-third of patients who developed a second primary BCC within 5 years did so during the first 6 months after diagnosis of the first.

The cumulative risk during the first 6 months of follow-up was extraordinarily high at 11.2%, as compared with 13.9% through 1 year, 18.5% after 2 years, 22.1% at 3 years, 25.5% after 4 years, and 29.2% after 5 years, she said. This translates into an incidence rate of 25,318 cases per 100,000 person-years during the first half-year after diagnosis of a first primary tumor.

"We think that this could indicate that these second BCCs that occur in the first 6 months after a first BCC diagnosis were already present at the date of the first BCC diagnosis, but were somehow missed then by the dermatologist or the doctor they went to," she said.

Still, the incidence rate remained quite high during the first several years of follow-up: 15,737 cases per 100,000 person-years through the first year and 10,779 per 100,000 person-years after 2 years before tailing off to 8,752 per 100,000 person-years at 3 years.

In a multivariate analysis, men had an adjusted 30% increased risk of developing one or more subsequent BCCs, and patients aged 65-79 years had an 81% greater risk than those under age 50.

Dr. Flohil declared having no financial conflicts of interest.

LISBON – Nearly 30% of patients diagnosed with a first pathologically confirmed basal cell carcinoma will develop one or more additional primary basal cell carcinomas within 5 years.

This finding, from a comprehensive Dutch national cancer registry, has important implications for clinical practice, noted Dr. Sophie C. Flohil at the annual congress of the European Academy of Dermatology and Venereology.

Courtesy Dr. Amit G. Pandya

"Based upon our results, we would like to recommend that all BCC [basal cell carcinoma] patients undergo annual follow-up visits with full-body skin examinations for at least 3 years after their first BCC diagnosis."

She presented a cohort study involving 2,483 consecutive unselected Dutch patients diagnosed with a first histological confirmed BCC during 2004.

During 5 years of prospective follow-up in PALGA, the Dutch nationwide network and registry of histo- and cytopathology, 29.2% of the patients were diagnosed with one or more additional primary BCCs, according to Dr. Flohil, a dermatology resident at Erasmus University, Rotterdam, the Netherlands.

More than one-third of patients who developed a second primary BCC within 5 years did so during the first 6 months after diagnosis of the first.

The cumulative risk during the first 6 months of follow-up was extraordinarily high at 11.2%, as compared with 13.9% through 1 year, 18.5% after 2 years, 22.1% at 3 years, 25.5% after 4 years, and 29.2% after 5 years, she said. This translates into an incidence rate of 25,318 cases per 100,000 person-years during the first half-year after diagnosis of a first primary tumor.

"We think that this could indicate that these second BCCs that occur in the first 6 months after a first BCC diagnosis were already present at the date of the first BCC diagnosis, but were somehow missed then by the dermatologist or the doctor they went to," she said.

Still, the incidence rate remained quite high during the first several years of follow-up: 15,737 cases per 100,000 person-years through the first year and 10,779 per 100,000 person-years after 2 years before tailing off to 8,752 per 100,000 person-years at 3 years.

In a multivariate analysis, men had an adjusted 30% increased risk of developing one or more subsequent BCCs, and patients aged 65-79 years had an 81% greater risk than those under age 50.

Dr. Flohil declared having no financial conflicts of interest.

LISBON – Validation of the interleukin-17 cytokine family in psoriasis pathophysiology has gotten a boost from positive, phase II clinical trials involving two novel biologic agents.

The double-blind, placebo-controlled, phase II studies documented rapid and marked improvement in patients who had moderate to severe plaque psoriasis and were treated with secukinumab or AMG 827.

Roughly 80% of patients who were randomized to the maximum dose of either biologic experienced at least a PASI 75 (that is, improvement of 75% as measured by the Psoriasis Area and Severity Index) at 12 weeks. Those are efficacy rates in excess of the improvement obtainable with the earlier-generation biologics that targeted tumor necrosis factor–alpha, according to Dr. Kim A. Papp, who presented the data on both drugs at the annual congress of the European Academy of Dermatology and Venereology.

"This is a very robust, profound response suggesting that we’re really getting to the fundamentals of what’s driving psoriasis," Dr. Papp said.

Secukinumab is the agent further along in the developmental pipeline. A phase III clinical trial is already underway on the strength of three phase II studies presented at the congress.

Secukinumab is a fully human monoclonal antibody targeting IL-17A, a key member of the IL-17 cytokine family. The sequence of pathophysiologic events in psoriasis, as understood today, is that IL-23 induces activated Th17 cells, which in lesional skin express IL-17, in turn eliciting the production of proinflammatory cytokines by keratinocytes and keratinocyte hyperproliferation. IL-17A is one of several types of IL-17 that bind to the IL-17 receptor.

In contrast, AMG 827 is a human monoclonal antibody that blocks the IL-17 receptor itself, explained Dr. Papp, director of research at Probity Medical Research Inc. in Waterloo, Ont.

Secukinumab: Study 1

Dr. Papp presented the results of two of the three phase II studies of secukinumab. One study randomized 125 patients to subcutaneous secukinumab of 150 mg, 75 mg, or 25 mg once monthly for 3 months; to a single 25-mg dose; or to placebo.

The primary end point (PASI 75 response rate at 12 weeks) was 81%, 57%, 19%, 3%, and 9%, respectively. PASI 90 (that is, an improvement of 90% on the PASI) response rates were 52%, 19%, 8%, 0%, and 5%, respectively. Investigator Global Assessment scores of clear or almost clear at 12 weeks were achieved in 48% of patients in the 150-mg group and in 33% of those who received 75 mg, which were significantly better ratings than the 0%-12% rates in the other study arms.

Secukinumab: Study 2

The second secukinumab phase II study that was presented by Dr. Papp examined possible intravenous induction doses. The 100 participants were randomized to 3 mg/kg given on day 1; to 10 mg/kg on day 1; to 10 mg/kg on days 1, 15, and 29; or to placebo. The PASI 75 rates at 12 weeks were 40%, 75%, 83%, and 10%, respectively. The PASI 90 response rates were 10%, 54%, 76%, and 0%.

Secukinumab: Study 3

Dr. Phoebe A. Rich presented the third secukinumab phase II trial, which aimed to find the best dosing regimen. The study included 404 patients at 63 centers in seven countries who were randomized 1:2:2:1 to subcutaneous placebo; to a single 150-mg dose at week 0; to 150 mg at weeks 0, 4, and 8; or to 150 mg at weeks 0, 1, 2, and 4.

The treatment arm with dosing at weeks 0, 1, 2 and 4 was the winner, with a PASI 75 response rate of 55% at week 12, compared with 42% with dosing at weeks 0, 4, and 8; 11% for a single dose; and 2% with placebo. The corresponding PASI 90 rates were 32%, 17%, 3%, and 2%, added Dr. Phoebe of the Oregon Dermatology and Research Center, Portland.

None of these relatively brief trials suggested any safety signals. The side effect pattern was basically the same as in the placebo arms, according to the investigators.

AMG 827

Dr. Papp also presented the first phase II, randomized, double-blind trial of AMG 827. It involved 198 patients who were randomized to subcutaneous AMG 827 at 280 mg monthly; to 70, 140, or 210 mg every 2 weeks; or to placebo. The primary end point was the PASI 75 response rate at week 12. It was highest (83%) in patients who received 210 mg every 2 weeks.

Interestingly, nearly all of the PASI 75 responders were also PASI 90 responders. The PASI 90 and PASI 100 response rates in the group taking 210 mg every 2 weeks were 75% and 63%, respectively. Again, as for secukinumab, the safety profile was unremarkable.

The response waned 4-10 weeks after the last dose of AMG 827. This took the form of a gradual, progressive relapse rather than an abrupt rebound, noted Dr. Papp.

Dr. Papp said that the large turnout to his presentation at the meeting, "shows the interest and excitement that surrounds what I think is a new adventure and really a new revolution in the understanding and treatment of psoriasis."

Dr. Papp is on the advisory boards of Novartis, which is developing secukinumab, and Amgen, manufacturer of AMG 827. He is also an advisor to many other pharmaceutical companies developing drugs for psoriasis. Dr. Rich is also on the advisory board of Novartis and other companies that are developing drugs for psoriasis.

LISBON – Validation of the interleukin-17 cytokine family in psoriasis pathophysiology has gotten a boost from positive, phase II clinical trials involving two novel biologic agents.

The double-blind, placebo-controlled, phase II studies documented rapid and marked improvement in patients who had moderate to severe plaque psoriasis and were treated with secukinumab or AMG 827.

Roughly 80% of patients who were randomized to the maximum dose of either biologic experienced at least a PASI 75 (that is, improvement of 75% as measured by the Psoriasis Area and Severity Index) at 12 weeks. Those are efficacy rates in excess of the improvement obtainable with the earlier-generation biologics that targeted tumor necrosis factor–alpha, according to Dr. Kim A. Papp, who presented the data on both drugs at the annual congress of the European Academy of Dermatology and Venereology.

"This is a very robust, profound response suggesting that we’re really getting to the fundamentals of what’s driving psoriasis," Dr. Papp said.

Secukinumab is the agent further along in the developmental pipeline. A phase III clinical trial is already underway on the strength of three phase II studies presented at the congress.

Secukinumab is a fully human monoclonal antibody targeting IL-17A, a key member of the IL-17 cytokine family. The sequence of pathophysiologic events in psoriasis, as understood today, is that IL-23 induces activated Th17 cells, which in lesional skin express IL-17, in turn eliciting the production of proinflammatory cytokines by keratinocytes and keratinocyte hyperproliferation. IL-17A is one of several types of IL-17 that bind to the IL-17 receptor.

In contrast, AMG 827 is a human monoclonal antibody that blocks the IL-17 receptor itself, explained Dr. Papp, director of research at Probity Medical Research Inc. in Waterloo, Ont.

Secukinumab: Study 1

Dr. Papp presented the results of two of the three phase II studies of secukinumab. One study randomized 125 patients to subcutaneous secukinumab of 150 mg, 75 mg, or 25 mg once monthly for 3 months; to a single 25-mg dose; or to placebo.

The primary end point (PASI 75 response rate at 12 weeks) was 81%, 57%, 19%, 3%, and 9%, respectively. PASI 90 (that is, an improvement of 90% on the PASI) response rates were 52%, 19%, 8%, 0%, and 5%, respectively. Investigator Global Assessment scores of clear or almost clear at 12 weeks were achieved in 48% of patients in the 150-mg group and in 33% of those who received 75 mg, which were significantly better ratings than the 0%-12% rates in the other study arms.

Secukinumab: Study 2

The second secukinumab phase II study that was presented by Dr. Papp examined possible intravenous induction doses. The 100 participants were randomized to 3 mg/kg given on day 1; to 10 mg/kg on day 1; to 10 mg/kg on days 1, 15, and 29; or to placebo. The PASI 75 rates at 12 weeks were 40%, 75%, 83%, and 10%, respectively. The PASI 90 response rates were 10%, 54%, 76%, and 0%.

Secukinumab: Study 3

Dr. Phoebe A. Rich presented the third secukinumab phase II trial, which aimed to find the best dosing regimen. The study included 404 patients at 63 centers in seven countries who were randomized 1:2:2:1 to subcutaneous placebo; to a single 150-mg dose at week 0; to 150 mg at weeks 0, 4, and 8; or to 150 mg at weeks 0, 1, 2, and 4.

The treatment arm with dosing at weeks 0, 1, 2 and 4 was the winner, with a PASI 75 response rate of 55% at week 12, compared with 42% with dosing at weeks 0, 4, and 8; 11% for a single dose; and 2% with placebo. The corresponding PASI 90 rates were 32%, 17%, 3%, and 2%, added Dr. Phoebe of the Oregon Dermatology and Research Center, Portland.

None of these relatively brief trials suggested any safety signals. The side effect pattern was basically the same as in the placebo arms, according to the investigators.

AMG 827

Dr. Papp also presented the first phase II, randomized, double-blind trial of AMG 827. It involved 198 patients who were randomized to subcutaneous AMG 827 at 280 mg monthly; to 70, 140, or 210 mg every 2 weeks; or to placebo. The primary end point was the PASI 75 response rate at week 12. It was highest (83%) in patients who received 210 mg every 2 weeks.

Interestingly, nearly all of the PASI 75 responders were also PASI 90 responders. The PASI 90 and PASI 100 response rates in the group taking 210 mg every 2 weeks were 75% and 63%, respectively. Again, as for secukinumab, the safety profile was unremarkable.

The response waned 4-10 weeks after the last dose of AMG 827. This took the form of a gradual, progressive relapse rather than an abrupt rebound, noted Dr. Papp.

Dr. Papp said that the large turnout to his presentation at the meeting, "shows the interest and excitement that surrounds what I think is a new adventure and really a new revolution in the understanding and treatment of psoriasis."

Dr. Papp is on the advisory boards of Novartis, which is developing secukinumab, and Amgen, manufacturer of AMG 827. He is also an advisor to many other pharmaceutical companies developing drugs for psoriasis. Dr. Rich is also on the advisory board of Novartis and other companies that are developing drugs for psoriasis.

LISBON – Validation of the interleukin-17 cytokine family in psoriasis pathophysiology has gotten a boost from positive, phase II clinical trials involving two novel biologic agents.

The double-blind, placebo-controlled, phase II studies documented rapid and marked improvement in patients who had moderate to severe plaque psoriasis and were treated with secukinumab or AMG 827.

Roughly 80% of patients who were randomized to the maximum dose of either biologic experienced at least a PASI 75 (that is, improvement of 75% as measured by the Psoriasis Area and Severity Index) at 12 weeks. Those are efficacy rates in excess of the improvement obtainable with the earlier-generation biologics that targeted tumor necrosis factor–alpha, according to Dr. Kim A. Papp, who presented the data on both drugs at the annual congress of the European Academy of Dermatology and Venereology.

"This is a very robust, profound response suggesting that we’re really getting to the fundamentals of what’s driving psoriasis," Dr. Papp said.

Secukinumab is the agent further along in the developmental pipeline. A phase III clinical trial is already underway on the strength of three phase II studies presented at the congress.

Secukinumab is a fully human monoclonal antibody targeting IL-17A, a key member of the IL-17 cytokine family. The sequence of pathophysiologic events in psoriasis, as understood today, is that IL-23 induces activated Th17 cells, which in lesional skin express IL-17, in turn eliciting the production of proinflammatory cytokines by keratinocytes and keratinocyte hyperproliferation. IL-17A is one of several types of IL-17 that bind to the IL-17 receptor.

In contrast, AMG 827 is a human monoclonal antibody that blocks the IL-17 receptor itself, explained Dr. Papp, director of research at Probity Medical Research Inc. in Waterloo, Ont.

Secukinumab: Study 1

Dr. Papp presented the results of two of the three phase II studies of secukinumab. One study randomized 125 patients to subcutaneous secukinumab of 150 mg, 75 mg, or 25 mg once monthly for 3 months; to a single 25-mg dose; or to placebo.

The primary end point (PASI 75 response rate at 12 weeks) was 81%, 57%, 19%, 3%, and 9%, respectively. PASI 90 (that is, an improvement of 90% on the PASI) response rates were 52%, 19%, 8%, 0%, and 5%, respectively. Investigator Global Assessment scores of clear or almost clear at 12 weeks were achieved in 48% of patients in the 150-mg group and in 33% of those who received 75 mg, which were significantly better ratings than the 0%-12% rates in the other study arms.

Secukinumab: Study 2

The second secukinumab phase II study that was presented by Dr. Papp examined possible intravenous induction doses. The 100 participants were randomized to 3 mg/kg given on day 1; to 10 mg/kg on day 1; to 10 mg/kg on days 1, 15, and 29; or to placebo. The PASI 75 rates at 12 weeks were 40%, 75%, 83%, and 10%, respectively. The PASI 90 response rates were 10%, 54%, 76%, and 0%.

Secukinumab: Study 3

Dr. Phoebe A. Rich presented the third secukinumab phase II trial, which aimed to find the best dosing regimen. The study included 404 patients at 63 centers in seven countries who were randomized 1:2:2:1 to subcutaneous placebo; to a single 150-mg dose at week 0; to 150 mg at weeks 0, 4, and 8; or to 150 mg at weeks 0, 1, 2, and 4.

The treatment arm with dosing at weeks 0, 1, 2 and 4 was the winner, with a PASI 75 response rate of 55% at week 12, compared with 42% with dosing at weeks 0, 4, and 8; 11% for a single dose; and 2% with placebo. The corresponding PASI 90 rates were 32%, 17%, 3%, and 2%, added Dr. Phoebe of the Oregon Dermatology and Research Center, Portland.

None of these relatively brief trials suggested any safety signals. The side effect pattern was basically the same as in the placebo arms, according to the investigators.

AMG 827

Dr. Papp also presented the first phase II, randomized, double-blind trial of AMG 827. It involved 198 patients who were randomized to subcutaneous AMG 827 at 280 mg monthly; to 70, 140, or 210 mg every 2 weeks; or to placebo. The primary end point was the PASI 75 response rate at week 12. It was highest (83%) in patients who received 210 mg every 2 weeks.

Interestingly, nearly all of the PASI 75 responders were also PASI 90 responders. The PASI 90 and PASI 100 response rates in the group taking 210 mg every 2 weeks were 75% and 63%, respectively. Again, as for secukinumab, the safety profile was unremarkable.

The response waned 4-10 weeks after the last dose of AMG 827. This took the form of a gradual, progressive relapse rather than an abrupt rebound, noted Dr. Papp.

Dr. Papp said that the large turnout to his presentation at the meeting, "shows the interest and excitement that surrounds what I think is a new adventure and really a new revolution in the understanding and treatment of psoriasis."

Dr. Papp is on the advisory boards of Novartis, which is developing secukinumab, and Amgen, manufacturer of AMG 827. He is also an advisor to many other pharmaceutical companies developing drugs for psoriasis. Dr. Rich is also on the advisory board of Novartis and other companies that are developing drugs for psoriasis.

SAN DIEGO – Angiotensin-converting enzyme inhibitor therapy may reduce the risk of age-related bone loss in elderly men.

A retrospective analysis of longitudinal data from the prospective Health ABC (Dynamics of Health, Aging and Body Composition Study) found that femoral neck bone mineral density was significantly greater in elderly men on an ACE inhibitor for 5 or more years for treatment of hypertension than in those who were not on long-term ACE inhibitor therapy, Dr. Nahid Rianon reported at the annual meeting of the American Society for Bone and Mineral Research.

This secondary analysis of Health ABC involved 583 men with a mean age of 83 years. At 10-year follow-up, femoral neck bone mineral density was 0.04 g/cm² greater in the 137 subjects on an ACE inhibitor for at least 5 years than in men not on long-term therapy with a drug in this class.

Of note, the same magnitude of improvement in femoral neck bone mineral density was seen after just 5 years of ACE inhibitor therapy. In other words, no further divergence in bone mineral density occurred during years 5-10.

These study findings warrant confirmation in a prospective clinical trial featuring analysis of bone markers, which wasn’t done in Health ABC. Osteoporosis and hypertension are two major age-related chronic diseases that at present are managed separately using different classes of drugs. If ACE inhibitors can be shown to be beneficial in both of these extremely common diseases, management would be considerably simplified, observed Dr. Rianon of the University of Texas, Houston.

The finding that long-term ACE inhibitor therapy appears to prevent age-related bone loss in older men has mechanistic plausibility, the physician continued. These drugs inhibit production of angiotensin II, a hormone that affects bone by binding to the angiotensin-1 and angiotensin-2 receptors expressed in osteoblasts, among other sites. And angiotensin-1 and angiotensin-2 expression appears to promote receptor-activated nuclear factor–kappaB ligand activity, which enhances bone loss.

Health ABC is sponsored by the National Institute on Aging. Dr. Rianon declared having no financial conflicts.

SAN DIEGO – Angiotensin-converting enzyme inhibitor therapy may reduce the risk of age-related bone loss in elderly men.

A retrospective analysis of longitudinal data from the prospective Health ABC (Dynamics of Health, Aging and Body Composition Study) found that femoral neck bone mineral density was significantly greater in elderly men on an ACE inhibitor for 5 or more years for treatment of hypertension than in those who were not on long-term ACE inhibitor therapy, Dr. Nahid Rianon reported at the annual meeting of the American Society for Bone and Mineral Research.

This secondary analysis of Health ABC involved 583 men with a mean age of 83 years. At 10-year follow-up, femoral neck bone mineral density was 0.04 g/cm² greater in the 137 subjects on an ACE inhibitor for at least 5 years than in men not on long-term therapy with a drug in this class.

Of note, the same magnitude of improvement in femoral neck bone mineral density was seen after just 5 years of ACE inhibitor therapy. In other words, no further divergence in bone mineral density occurred during years 5-10.

These study findings warrant confirmation in a prospective clinical trial featuring analysis of bone markers, which wasn’t done in Health ABC. Osteoporosis and hypertension are two major age-related chronic diseases that at present are managed separately using different classes of drugs. If ACE inhibitors can be shown to be beneficial in both of these extremely common diseases, management would be considerably simplified, observed Dr. Rianon of the University of Texas, Houston.

The finding that long-term ACE inhibitor therapy appears to prevent age-related bone loss in older men has mechanistic plausibility, the physician continued. These drugs inhibit production of angiotensin II, a hormone that affects bone by binding to the angiotensin-1 and angiotensin-2 receptors expressed in osteoblasts, among other sites. And angiotensin-1 and angiotensin-2 expression appears to promote receptor-activated nuclear factor–kappaB ligand activity, which enhances bone loss.

Health ABC is sponsored by the National Institute on Aging. Dr. Rianon declared having no financial conflicts.

SAN DIEGO – Angiotensin-converting enzyme inhibitor therapy may reduce the risk of age-related bone loss in elderly men.

A retrospective analysis of longitudinal data from the prospective Health ABC (Dynamics of Health, Aging and Body Composition Study) found that femoral neck bone mineral density was significantly greater in elderly men on an ACE inhibitor for 5 or more years for treatment of hypertension than in those who were not on long-term ACE inhibitor therapy, Dr. Nahid Rianon reported at the annual meeting of the American Society for Bone and Mineral Research.

This secondary analysis of Health ABC involved 583 men with a mean age of 83 years. At 10-year follow-up, femoral neck bone mineral density was 0.04 g/cm² greater in the 137 subjects on an ACE inhibitor for at least 5 years than in men not on long-term therapy with a drug in this class.

Of note, the same magnitude of improvement in femoral neck bone mineral density was seen after just 5 years of ACE inhibitor therapy. In other words, no further divergence in bone mineral density occurred during years 5-10.

These study findings warrant confirmation in a prospective clinical trial featuring analysis of bone markers, which wasn’t done in Health ABC. Osteoporosis and hypertension are two major age-related chronic diseases that at present are managed separately using different classes of drugs. If ACE inhibitors can be shown to be beneficial in both of these extremely common diseases, management would be considerably simplified, observed Dr. Rianon of the University of Texas, Houston.

The finding that long-term ACE inhibitor therapy appears to prevent age-related bone loss in older men has mechanistic plausibility, the physician continued. These drugs inhibit production of angiotensin II, a hormone that affects bone by binding to the angiotensin-1 and angiotensin-2 receptors expressed in osteoblasts, among other sites. And angiotensin-1 and angiotensin-2 expression appears to promote receptor-activated nuclear factor–kappaB ligand activity, which enhances bone loss.

Health ABC is sponsored by the National Institute on Aging. Dr. Rianon declared having no financial conflicts.

SAN DIEGO – The World Health Organization’s widely used, Web-based fracture risk assessment tool known as FRAX seriously underestimates the risk of major osteoporotic and hip fractures in patients with diabetes, according to a large Canadian study.

This finding indicates diabetes is an independent risk factor for fractures above and beyond the conventional risk factors incorporated in the FRAX tool, which include age, gender, smoking, fracture history, and glucocorticoid use – but not diabetes.

"One implication of our findings is that FRAX should be applied cautiously in clinical situations involving diabetic patients," Lora Giangregorio, Ph.D., said at the annual meeting of the American Society for Bone and Mineral Research.

"Future iterations of the FRAX tool might consider adding diabetes to the list of risk factors," added Dr. Giangregorio of the University of Waterloo (Ontario).

She presented an analysis of a large Manitoba Province–wide database that included 3,518 patients with type 1 or type 2 diabetes and 36,085 nondiabetic controls, all at least 50 years old when they underwent bone mineral density testing during 1987-2008.

The FRAX tool was used to calculate 10-year fracture risk probabilities, and the actual incidence of major osteoporotic or hip fractures was determined through 2008.

The key finding: After the researchers controlled for FRAX fracture probability scores and the use of osteoporotic medications, diabetes was independently associated with a 59% increased fracture rate during an average 10 years of follow-up.

Of note, despite the increased fracture rate documented in diabetic patients in this study, a lower proportion of subjects with diabetes were receiving osteoporotic medications, compared with the nondiabetes population, Dr. Giangregorio observed.

Diabetes was a stronger predictor of hip fracture risk in younger subjects. Indeed, it was independently associated with a 5.3-fold increased risk of hip fracture in individuals younger than age 65, compared with a 2.1-fold increase in those who were older. In contrast, the risk of major osteoporotic fractures in diabetic patients was not related to age.

The fracture probability curves for diabetic and nondiabetic subjects diverged from the beginning of follow-up and continued to separate throughout the study period.

An important area for future research, in Dr. Giangregorio’s view, is the identification of potentially modifiable diabetes-related fracture risk factors. As a hypothetical example, perhaps some diabetes medications are associated with an increase in fractures while others are not.

"Future iterations of the FRAX tool might consider adding diabetes to the list of risk factors."

The study did not differentiate between type 1 and type 2 diabetes. However, in another study presented at the meeting, Dr. Ling Oei of Erasmus University, Rotterdam, the Netherlands, noted that patients with type 2 diabetes are paradoxically at increased risk of osteoporotic fractures even though their bone mineral density is typically normal or even increased.

In a prospective, population-based study of 203 patients with adequately controlled type 2 diabetes, 217 others with inadequately controlled disease, and 3,715 nondiabetic controls, Dr. Oei and coworkers showed that women with inadequately controlled diabetes had significantly higher bone mineral density at both the lumbar spine and femoral neck, compared with women in the other two groups.

After the researchers controlled for age, femoral neck bone mineral density, and body mass index, women with inadequately controlled type 2 diabetes had a 1.6-fold increased risk of fracture during an average 8.2-year follow-up, compared with patients who had adequately controlled type 2 diabetes or patients without diabetes. In other words, inadequate control of type 2 diabetes appears to be a risk factor for fracture in elderly women but not men, according to the Dutch investigators.

Dr. Giangregorio and Dr. Oei reported having no financial conflicts.

SAN DIEGO – The World Health Organization’s widely used, Web-based fracture risk assessment tool known as FRAX seriously underestimates the risk of major osteoporotic and hip fractures in patients with diabetes, according to a large Canadian study.

This finding indicates diabetes is an independent risk factor for fractures above and beyond the conventional risk factors incorporated in the FRAX tool, which include age, gender, smoking, fracture history, and glucocorticoid use – but not diabetes.

"One implication of our findings is that FRAX should be applied cautiously in clinical situations involving diabetic patients," Lora Giangregorio, Ph.D., said at the annual meeting of the American Society for Bone and Mineral Research.

"Future iterations of the FRAX tool might consider adding diabetes to the list of risk factors," added Dr. Giangregorio of the University of Waterloo (Ontario).

She presented an analysis of a large Manitoba Province–wide database that included 3,518 patients with type 1 or type 2 diabetes and 36,085 nondiabetic controls, all at least 50 years old when they underwent bone mineral density testing during 1987-2008.

The FRAX tool was used to calculate 10-year fracture risk probabilities, and the actual incidence of major osteoporotic or hip fractures was determined through 2008.

The key finding: After the researchers controlled for FRAX fracture probability scores and the use of osteoporotic medications, diabetes was independently associated with a 59% increased fracture rate during an average 10 years of follow-up.

Of note, despite the increased fracture rate documented in diabetic patients in this study, a lower proportion of subjects with diabetes were receiving osteoporotic medications, compared with the nondiabetes population, Dr. Giangregorio observed.

Diabetes was a stronger predictor of hip fracture risk in younger subjects. Indeed, it was independently associated with a 5.3-fold increased risk of hip fracture in individuals younger than age 65, compared with a 2.1-fold increase in those who were older. In contrast, the risk of major osteoporotic fractures in diabetic patients was not related to age.

The fracture probability curves for diabetic and nondiabetic subjects diverged from the beginning of follow-up and continued to separate throughout the study period.

An important area for future research, in Dr. Giangregorio’s view, is the identification of potentially modifiable diabetes-related fracture risk factors. As a hypothetical example, perhaps some diabetes medications are associated with an increase in fractures while others are not.

"Future iterations of the FRAX tool might consider adding diabetes to the list of risk factors."

The study did not differentiate between type 1 and type 2 diabetes. However, in another study presented at the meeting, Dr. Ling Oei of Erasmus University, Rotterdam, the Netherlands, noted that patients with type 2 diabetes are paradoxically at increased risk of osteoporotic fractures even though their bone mineral density is typically normal or even increased.

In a prospective, population-based study of 203 patients with adequately controlled type 2 diabetes, 217 others with inadequately controlled disease, and 3,715 nondiabetic controls, Dr. Oei and coworkers showed that women with inadequately controlled diabetes had significantly higher bone mineral density at both the lumbar spine and femoral neck, compared with women in the other two groups.

After the researchers controlled for age, femoral neck bone mineral density, and body mass index, women with inadequately controlled type 2 diabetes had a 1.6-fold increased risk of fracture during an average 8.2-year follow-up, compared with patients who had adequately controlled type 2 diabetes or patients without diabetes. In other words, inadequate control of type 2 diabetes appears to be a risk factor for fracture in elderly women but not men, according to the Dutch investigators.

Dr. Giangregorio and Dr. Oei reported having no financial conflicts.

SAN DIEGO – The World Health Organization’s widely used, Web-based fracture risk assessment tool known as FRAX seriously underestimates the risk of major osteoporotic and hip fractures in patients with diabetes, according to a large Canadian study.

This finding indicates diabetes is an independent risk factor for fractures above and beyond the conventional risk factors incorporated in the FRAX tool, which include age, gender, smoking, fracture history, and glucocorticoid use – but not diabetes.

"One implication of our findings is that FRAX should be applied cautiously in clinical situations involving diabetic patients," Lora Giangregorio, Ph.D., said at the annual meeting of the American Society for Bone and Mineral Research.

"Future iterations of the FRAX tool might consider adding diabetes to the list of risk factors," added Dr. Giangregorio of the University of Waterloo (Ontario).

She presented an analysis of a large Manitoba Province–wide database that included 3,518 patients with type 1 or type 2 diabetes and 36,085 nondiabetic controls, all at least 50 years old when they underwent bone mineral density testing during 1987-2008.

The FRAX tool was used to calculate 10-year fracture risk probabilities, and the actual incidence of major osteoporotic or hip fractures was determined through 2008.

The key finding: After the researchers controlled for FRAX fracture probability scores and the use of osteoporotic medications, diabetes was independently associated with a 59% increased fracture rate during an average 10 years of follow-up.

Of note, despite the increased fracture rate documented in diabetic patients in this study, a lower proportion of subjects with diabetes were receiving osteoporotic medications, compared with the nondiabetes population, Dr. Giangregorio observed.

Diabetes was a stronger predictor of hip fracture risk in younger subjects. Indeed, it was independently associated with a 5.3-fold increased risk of hip fracture in individuals younger than age 65, compared with a 2.1-fold increase in those who were older. In contrast, the risk of major osteoporotic fractures in diabetic patients was not related to age.

The fracture probability curves for diabetic and nondiabetic subjects diverged from the beginning of follow-up and continued to separate throughout the study period.

An important area for future research, in Dr. Giangregorio’s view, is the identification of potentially modifiable diabetes-related fracture risk factors. As a hypothetical example, perhaps some diabetes medications are associated with an increase in fractures while others are not.

"Future iterations of the FRAX tool might consider adding diabetes to the list of risk factors."

The study did not differentiate between type 1 and type 2 diabetes. However, in another study presented at the meeting, Dr. Ling Oei of Erasmus University, Rotterdam, the Netherlands, noted that patients with type 2 diabetes are paradoxically at increased risk of osteoporotic fractures even though their bone mineral density is typically normal or even increased.

In a prospective, population-based study of 203 patients with adequately controlled type 2 diabetes, 217 others with inadequately controlled disease, and 3,715 nondiabetic controls, Dr. Oei and coworkers showed that women with inadequately controlled diabetes had significantly higher bone mineral density at both the lumbar spine and femoral neck, compared with women in the other two groups.

After the researchers controlled for age, femoral neck bone mineral density, and body mass index, women with inadequately controlled type 2 diabetes had a 1.6-fold increased risk of fracture during an average 8.2-year follow-up, compared with patients who had adequately controlled type 2 diabetes or patients without diabetes. In other words, inadequate control of type 2 diabetes appears to be a risk factor for fracture in elderly women but not men, according to the Dutch investigators.

Dr. Giangregorio and Dr. Oei reported having no financial conflicts.

BOULDER, COLO. – A buzz of excitement – a sense of history in the making – was palpable as the newly incorporated Society of Ob/Gyn Hospitalists held its first-ever annual meeting.

"We are all witnessing the birth of a new subspecialty," declared Dr. Brigid McCue, an ob.gyn. hospitalist at Jordan Hospital in Plymouth, Mass., and a member of the Society of Ob/Gyn Hospitalists (SOGH) steering committee.

Present at the birth were officials from both the American College of Obstetricians and Gynecologists (ACOG) and the Society of Hospital Medicine (SHM), two organizations interested in having close ties with the new medical society.

"ACOG recognizes this is the new paradigm of care," said Dr. J. Joshua Kopelman, chair of ACOG District VIII. "We absolutely want you to be people who provide input about what you do to all of the committees at the executive level of the college."

"Ob.gyn. hospitalists in this country are the wave of the future. There’s no question about it. The model has been going on for a long time in Great Britain, for example, where you have people whose practices are office-based, and you have people who work full time in the hospital and that’s all they do. They’ve had to learn how to do patient handoffs between these two groups of physicians," he added.

Dr. Shaun Frost, president-elect of the SHM, observed that "it’s kind of mind-boggling" to see the parallels between the birth of that organization and the SOGH. Both groups began with a small cadre of enthusiastic people full of outside-the-box ideas about how to improve patient care in the hospital.

Hospital medicine has experienced astronomical growth. The SHM consisted of 23 members in 1997, the year of its birth. Membership climbed to 800 just 2 years later, then to 3,200 in 2003, 6,300 in 2006, and now sits at about 12,000.

"I would anticipate that you’re going to experience the same thing we did in terms of rapid and significant growth. Tighten your seat belts – it can be a wild ride sometimes, but I can tell you that for me, after 14 years, it has been nothing short of profoundly gratifying," said Dr. Frost, who is chief medical officer for the Northeast region of Cogent HMG Healthcare and an internist at the University of Minnesota, Minneapolis.

In an interview, meeting cochair Dr. Rob Olson said at present there are 143 ob.gyn. hospitalist groups spread throughout the country, typically with four to six hospitalists each. Most work 12-hour shifts, some 24-hour shifts.

"Right now hospitalists are doing a very small percentage of all deliveries, maybe 2%. I project in 5 years we’ll be doing 20% or 25%," predicted Dr. Olson, an ob.gyn. hospitalist in Bellingham, Wash., and founder of www.obgynhospitalist.com.

The primary mission of ob.gyn. hospitalists is to enhance patient safety in the hospital, he explained. If an emergency requiring cesarean section occurs, the hospitalist can start the operation while the private obstetrician is en route, shifting to second assistant when the private physician arrives and takes over the procedure. Or if a woman who has been in labor for a few hours begins progressing rapidly at 2 a.m., the hospitalist can step in and do the delivery if the private physician can’t get to the hospital promptly.

Hospitalists can also provide support when a midwife or family physician has a complicated delivery requiring a vacuum extraction, forceps, or a cesarean section.

"It’s kind of like being a lifeguard, where you’re sitting at the beach waiting for the problem," he said.

Ordinarily a hospitalist will never see a patient antepartum. The exception is the unassigned patient who may drop in to the hospital with no prenatal care, who then becomes the hospitalist’s responsibility.

Hospitalists also support private physicians by letting them sign out patients as a convenience.

"A private physician may say, ‘I’ve got a big surgery tomorrow. Can you take care of all of my patients between midnight and 6 a.m. so I can sleep?’ That’s another way of utilizing us," Dr. Olson continued.

In the initial months following introduction of an ob.gyn. hospitalist program, however, patient sign-outs typically aren’t a substantial part of the job.

"At the beginning the private doctors are a little worried about it. They don’t want to sign out. They’re suspicious. They’re afraid that they’re going to give up not only their patients but their revenue. When they realize how helpful check outs are, though, then they sign out," he explained.

Some ob.gyn. hospitalists are laborists only and prefer it that way. Others, including Dr. McCue, also cover gynecologic cases in the emergency department.

"I have diagnosed more horrific cancers in 18 months as a hospitalist than in 13 years of private practice," Dr. McCue said, adding that she feels good about covering gynecologic cases in the ER because it enables her to maintain some of her hard-earned gynecologic skills.

Several audience members voiced discomfort about leaving the labor and delivery area to taking on emergency department gynecologic surgical cases because it distracts from the primary hospitalist focus of saving babies. Dr. McCue responded that the answer is to negotiate boundaries.

"What most of the hospitalist programs are coming to is making a deal with the privates," she explained. "You say, ‘I am doing the vast majority of your nighttime work by covering the labor floor for you and covering the first calls for you. All that I ask is that you be available on an emergency basis for the ER overload that I can’t handle. I am happy to get the ectopics and incompletes started for you, but if I call that’s because I need you to be there to cover.’ "

Conference attendees heard best-practice updates from authorities on obstetric triage and evidence-based cesarean section techniques. They also began planning SOGH’s future course. Dr. Bob Fagnant circulated a rough draft of proposed core competencies defining what ob.gyn. hospitalists need to be able to do.

The society will eventually have to formally settle on a group of core competencies, a program for attaining them, and a means of tracking them to attain subspecialty status from the American Board of Obstetrics and Gynecology. The board will want to see evidence that being an ob.gyn. hospitalist requires a special set of skills not taught to physicians who graduate residency as a general ob.gyns., explained Dr. Fagnant, an ob.gyn. hospitalist at Intermountain Health Care in St. George, Utah, who is also vice chair of the ACOG Committee on Ambulatory Practice.

The SOGH leadership believes simulation training will play a key role in demonstrating ob.gyn. hospitalist competencies. Toward that end, SOGH’s first annual meeting featured a half-day of participation in a three-station obstetrical emergency simulation workshop focused on management of obstetric hemorrhage, maneuvers and techniques to relieve shoulder dystocia, and operative deliveries.

Dr. Arthur Townsend, medical director of the ob.gyn. hospitalist program at Methodist Le-Bonheur Hospital in Germantown, Tenn., stressed that hospitalists are "perfectly positioned" to support the quality initiatives hospitals take on to improve outcomes, decrease liability, attract patients, and meet the requirements of outside national organizations that report on quality indicators, such as the National Perinatal Information Center/Quality Analytic Services.

A significant part of what he and his hospitalist colleagues do is gather statistics. These include hospital-wide cesarean rates, vaginal births after cesarean, incidence of episiotomy, third- and fourth-degree laceration rates, postpartum hemorrhage, vaginal deliveries with shoulder dystocia, and a host of others.

He and his fellow hospitalists also carefully track their own performance. They file a detailed online report at a secure website upon completing every shift. These shift reports are compiled into monthly reports totaling the number of deliveries the hospitalists have performed, assists provided at cesarean and vaginal deliveries, the emergencies hospitalists responded to, the number of gynecologic surgeries performed, unassigned patients they’ve seen, and nurse and physician satisfaction survey results. These reports go to the hospital CEO, the board of directors, and the hospital risk management and quality committees.

"We’ve got some data to show that we really make a difference. What we do in these reports is tell how we save people. Everyone wants to know how many patients we’re saving," he explained.

The hospitalists track and submit individual physician-level statistics. When the data point to a problem physician – for example, an ob.gyn. who doesn’t return phone calls from a nighttime nurse in timely fashion or who regularly scores poorly in patient satisfaction – Dr. Townsend leaves it to the hospital quality committee to do something about it.

"I don’t want to be the sheriff," he explained.

These data-filled reports document the progress the hospital has made in achieving safety. This in turn has led to a reduction in the cost of the hospital’s risk insurance. Moreover, when Dr. Townsend made a presentation to the hospital’s risk underwriter, the company was so favorably impressed by what ob.gyn. hospitalists do that it provided them with a $60,000 grant to purchase obstetrical emergency simulators.

Dr. Townsend asked audience members to think about which hospitalist quality measures they consider to be most important yet practical for hospitalist practices to routinely collect at the national level. This is an issue where SOGH would like to be able to provide recommendations.

Dr. Suneet P. Chauhan, a non-hospitalist guest speaker at the conference, recommended focusing initially on two key statistics where he believes ob.gyn. hospitalists could make an impact with maximum "wow" factor: time to cesarean section for nonreassuring fetal heart rate tracings, and time spent in obstetric triage for preterm labor.

"As everyone knows, in one-third of cases the decision-to-incision time in an emergency c-section is not met. The lawyers know that, too. You, more than any other person in the hospital, can decrease the decision-to-incision time," he told the hospitalists.

"You can also really help in obstetric triage. Triage is a very expensive place. In our hospital a patient could be there 3-6 hours before being seen. But if hospitalists routinely adopted the use of transvaginal cervical length measurement and/or fetal fibronectin, it would really shorten the stay at triage," predicted Dr. Chauhan, director of maternal-fetal medicine and professor of ob.gyn. at Eastern Virginia Medical School, Norfolk.

Dr. Frost, the SHM president-elect, shared five key lessons he believes to be essential in building a hospitalist medical society from scratch, based upon the SHM experience: focus keenly on quality improvement; seek to be recognized by external stakeholders as health care reform facilitators, not obstructionists; respect the power of ‘branding" as hospitalists; define your members’ uniqueness; and be an inclusive "big tent" organization rather than exclusive in terms of membership.

ACOG District VIII Chair Dr. Kopelman urged SOGH members to make their viewpoint heard at ACOG by becoming active at the section and district level, then applying for one of the roughly 50 new committee appointments made each year. Natural fits for SOGH members might be the Committee on Patient Safety and Quality Improvement, the Committee on Obstetric Practice, the Committee on Professional Liability, the Precis Advisory Committee, and the Council on Resident Education in Obstetrics and Gynecology.

He also urged SOGH leaders to enroll in ACOG’s Robert C. Cefalo National Leadership Institute.

"It’s absolutely the most valuable thing that I ever did in my involvement with ACOG. It was a career-changing event to have attended that institute," according to Dr. Kopelman.

Dr. Frost noted that the SHM also offers a leadership academy for its members, as well as a practice management institute which provides instruction in hospitalist business operations.

SOGH leaders urged their members to seriously consider belonging to both ACOG and SHM, two organizations having the ear of health policy makers.

BOULDER, COLO. – A buzz of excitement – a sense of history in the making – was palpable as the newly incorporated Society of Ob/Gyn Hospitalists held its first-ever annual meeting.

"We are all witnessing the birth of a new subspecialty," declared Dr. Brigid McCue, an ob.gyn. hospitalist at Jordan Hospital in Plymouth, Mass., and a member of the Society of Ob/Gyn Hospitalists (SOGH) steering committee.

Present at the birth were officials from both the American College of Obstetricians and Gynecologists (ACOG) and the Society of Hospital Medicine (SHM), two organizations interested in having close ties with the new medical society.

"ACOG recognizes this is the new paradigm of care," said Dr. J. Joshua Kopelman, chair of ACOG District VIII. "We absolutely want you to be people who provide input about what you do to all of the committees at the executive level of the college."

"Ob.gyn. hospitalists in this country are the wave of the future. There’s no question about it. The model has been going on for a long time in Great Britain, for example, where you have people whose practices are office-based, and you have people who work full time in the hospital and that’s all they do. They’ve had to learn how to do patient handoffs between these two groups of physicians," he added.

Dr. Shaun Frost, president-elect of the SHM, observed that "it’s kind of mind-boggling" to see the parallels between the birth of that organization and the SOGH. Both groups began with a small cadre of enthusiastic people full of outside-the-box ideas about how to improve patient care in the hospital.

Hospital medicine has experienced astronomical growth. The SHM consisted of 23 members in 1997, the year of its birth. Membership climbed to 800 just 2 years later, then to 3,200 in 2003, 6,300 in 2006, and now sits at about 12,000.

"I would anticipate that you’re going to experience the same thing we did in terms of rapid and significant growth. Tighten your seat belts – it can be a wild ride sometimes, but I can tell you that for me, after 14 years, it has been nothing short of profoundly gratifying," said Dr. Frost, who is chief medical officer for the Northeast region of Cogent HMG Healthcare and an internist at the University of Minnesota, Minneapolis.

In an interview, meeting cochair Dr. Rob Olson said at present there are 143 ob.gyn. hospitalist groups spread throughout the country, typically with four to six hospitalists each. Most work 12-hour shifts, some 24-hour shifts.

"Right now hospitalists are doing a very small percentage of all deliveries, maybe 2%. I project in 5 years we’ll be doing 20% or 25%," predicted Dr. Olson, an ob.gyn. hospitalist in Bellingham, Wash., and founder of www.obgynhospitalist.com.

The primary mission of ob.gyn. hospitalists is to enhance patient safety in the hospital, he explained. If an emergency requiring cesarean section occurs, the hospitalist can start the operation while the private obstetrician is en route, shifting to second assistant when the private physician arrives and takes over the procedure. Or if a woman who has been in labor for a few hours begins progressing rapidly at 2 a.m., the hospitalist can step in and do the delivery if the private physician can’t get to the hospital promptly.

Hospitalists can also provide support when a midwife or family physician has a complicated delivery requiring a vacuum extraction, forceps, or a cesarean section.

"It’s kind of like being a lifeguard, where you’re sitting at the beach waiting for the problem," he said.

Ordinarily a hospitalist will never see a patient antepartum. The exception is the unassigned patient who may drop in to the hospital with no prenatal care, who then becomes the hospitalist’s responsibility.

Hospitalists also support private physicians by letting them sign out patients as a convenience.

"A private physician may say, ‘I’ve got a big surgery tomorrow. Can you take care of all of my patients between midnight and 6 a.m. so I can sleep?’ That’s another way of utilizing us," Dr. Olson continued.

In the initial months following introduction of an ob.gyn. hospitalist program, however, patient sign-outs typically aren’t a substantial part of the job.

"At the beginning the private doctors are a little worried about it. They don’t want to sign out. They’re suspicious. They’re afraid that they’re going to give up not only their patients but their revenue. When they realize how helpful check outs are, though, then they sign out," he explained.

Some ob.gyn. hospitalists are laborists only and prefer it that way. Others, including Dr. McCue, also cover gynecologic cases in the emergency department.

"I have diagnosed more horrific cancers in 18 months as a hospitalist than in 13 years of private practice," Dr. McCue said, adding that she feels good about covering gynecologic cases in the ER because it enables her to maintain some of her hard-earned gynecologic skills.

Several audience members voiced discomfort about leaving the labor and delivery area to taking on emergency department gynecologic surgical cases because it distracts from the primary hospitalist focus of saving babies. Dr. McCue responded that the answer is to negotiate boundaries.

"What most of the hospitalist programs are coming to is making a deal with the privates," she explained. "You say, ‘I am doing the vast majority of your nighttime work by covering the labor floor for you and covering the first calls for you. All that I ask is that you be available on an emergency basis for the ER overload that I can’t handle. I am happy to get the ectopics and incompletes started for you, but if I call that’s because I need you to be there to cover.’ "

Conference attendees heard best-practice updates from authorities on obstetric triage and evidence-based cesarean section techniques. They also began planning SOGH’s future course. Dr. Bob Fagnant circulated a rough draft of proposed core competencies defining what ob.gyn. hospitalists need to be able to do.

The society will eventually have to formally settle on a group of core competencies, a program for attaining them, and a means of tracking them to attain subspecialty status from the American Board of Obstetrics and Gynecology. The board will want to see evidence that being an ob.gyn. hospitalist requires a special set of skills not taught to physicians who graduate residency as a general ob.gyns., explained Dr. Fagnant, an ob.gyn. hospitalist at Intermountain Health Care in St. George, Utah, who is also vice chair of the ACOG Committee on Ambulatory Practice.

The SOGH leadership believes simulation training will play a key role in demonstrating ob.gyn. hospitalist competencies. Toward that end, SOGH’s first annual meeting featured a half-day of participation in a three-station obstetrical emergency simulation workshop focused on management of obstetric hemorrhage, maneuvers and techniques to relieve shoulder dystocia, and operative deliveries.

Dr. Arthur Townsend, medical director of the ob.gyn. hospitalist program at Methodist Le-Bonheur Hospital in Germantown, Tenn., stressed that hospitalists are "perfectly positioned" to support the quality initiatives hospitals take on to improve outcomes, decrease liability, attract patients, and meet the requirements of outside national organizations that report on quality indicators, such as the National Perinatal Information Center/Quality Analytic Services.

A significant part of what he and his hospitalist colleagues do is gather statistics. These include hospital-wide cesarean rates, vaginal births after cesarean, incidence of episiotomy, third- and fourth-degree laceration rates, postpartum hemorrhage, vaginal deliveries with shoulder dystocia, and a host of others.

He and his fellow hospitalists also carefully track their own performance. They file a detailed online report at a secure website upon completing every shift. These shift reports are compiled into monthly reports totaling the number of deliveries the hospitalists have performed, assists provided at cesarean and vaginal deliveries, the emergencies hospitalists responded to, the number of gynecologic surgeries performed, unassigned patients they’ve seen, and nurse and physician satisfaction survey results. These reports go to the hospital CEO, the board of directors, and the hospital risk management and quality committees.

"We’ve got some data to show that we really make a difference. What we do in these reports is tell how we save people. Everyone wants to know how many patients we’re saving," he explained.

The hospitalists track and submit individual physician-level statistics. When the data point to a problem physician – for example, an ob.gyn. who doesn’t return phone calls from a nighttime nurse in timely fashion or who regularly scores poorly in patient satisfaction – Dr. Townsend leaves it to the hospital quality committee to do something about it.

"I don’t want to be the sheriff," he explained.

These data-filled reports document the progress the hospital has made in achieving safety. This in turn has led to a reduction in the cost of the hospital’s risk insurance. Moreover, when Dr. Townsend made a presentation to the hospital’s risk underwriter, the company was so favorably impressed by what ob.gyn. hospitalists do that it provided them with a $60,000 grant to purchase obstetrical emergency simulators.

Dr. Townsend asked audience members to think about which hospitalist quality measures they consider to be most important yet practical for hospitalist practices to routinely collect at the national level. This is an issue where SOGH would like to be able to provide recommendations.

Dr. Suneet P. Chauhan, a non-hospitalist guest speaker at the conference, recommended focusing initially on two key statistics where he believes ob.gyn. hospitalists could make an impact with maximum "wow" factor: time to cesarean section for nonreassuring fetal heart rate tracings, and time spent in obstetric triage for preterm labor.

"As everyone knows, in one-third of cases the decision-to-incision time in an emergency c-section is not met. The lawyers know that, too. You, more than any other person in the hospital, can decrease the decision-to-incision time," he told the hospitalists.

"You can also really help in obstetric triage. Triage is a very expensive place. In our hospital a patient could be there 3-6 hours before being seen. But if hospitalists routinely adopted the use of transvaginal cervical length measurement and/or fetal fibronectin, it would really shorten the stay at triage," predicted Dr. Chauhan, director of maternal-fetal medicine and professor of ob.gyn. at Eastern Virginia Medical School, Norfolk.

Dr. Frost, the SHM president-elect, shared five key lessons he believes to be essential in building a hospitalist medical society from scratch, based upon the SHM experience: focus keenly on quality improvement; seek to be recognized by external stakeholders as health care reform facilitators, not obstructionists; respect the power of ‘branding" as hospitalists; define your members’ uniqueness; and be an inclusive "big tent" organization rather than exclusive in terms of membership.

ACOG District VIII Chair Dr. Kopelman urged SOGH members to make their viewpoint heard at ACOG by becoming active at the section and district level, then applying for one of the roughly 50 new committee appointments made each year. Natural fits for SOGH members might be the Committee on Patient Safety and Quality Improvement, the Committee on Obstetric Practice, the Committee on Professional Liability, the Precis Advisory Committee, and the Council on Resident Education in Obstetrics and Gynecology.

He also urged SOGH leaders to enroll in ACOG’s Robert C. Cefalo National Leadership Institute.

"It’s absolutely the most valuable thing that I ever did in my involvement with ACOG. It was a career-changing event to have attended that institute," according to Dr. Kopelman.

Dr. Frost noted that the SHM also offers a leadership academy for its members, as well as a practice management institute which provides instruction in hospitalist business operations.

SOGH leaders urged their members to seriously consider belonging to both ACOG and SHM, two organizations having the ear of health policy makers.

BOULDER, COLO. – A buzz of excitement – a sense of history in the making – was palpable as the newly incorporated Society of Ob/Gyn Hospitalists held its first-ever annual meeting.

"We are all witnessing the birth of a new subspecialty," declared Dr. Brigid McCue, an ob.gyn. hospitalist at Jordan Hospital in Plymouth, Mass., and a member of the Society of Ob/Gyn Hospitalists (SOGH) steering committee.

Present at the birth were officials from both the American College of Obstetricians and Gynecologists (ACOG) and the Society of Hospital Medicine (SHM), two organizations interested in having close ties with the new medical society.

"ACOG recognizes this is the new paradigm of care," said Dr. J. Joshua Kopelman, chair of ACOG District VIII. "We absolutely want you to be people who provide input about what you do to all of the committees at the executive level of the college."

"Ob.gyn. hospitalists in this country are the wave of the future. There’s no question about it. The model has been going on for a long time in Great Britain, for example, where you have people whose practices are office-based, and you have people who work full time in the hospital and that’s all they do. They’ve had to learn how to do patient handoffs between these two groups of physicians," he added.

Dr. Shaun Frost, president-elect of the SHM, observed that "it’s kind of mind-boggling" to see the parallels between the birth of that organization and the SOGH. Both groups began with a small cadre of enthusiastic people full of outside-the-box ideas about how to improve patient care in the hospital.

Hospital medicine has experienced astronomical growth. The SHM consisted of 23 members in 1997, the year of its birth. Membership climbed to 800 just 2 years later, then to 3,200 in 2003, 6,300 in 2006, and now sits at about 12,000.

"I would anticipate that you’re going to experience the same thing we did in terms of rapid and significant growth. Tighten your seat belts – it can be a wild ride sometimes, but I can tell you that for me, after 14 years, it has been nothing short of profoundly gratifying," said Dr. Frost, who is chief medical officer for the Northeast region of Cogent HMG Healthcare and an internist at the University of Minnesota, Minneapolis.

In an interview, meeting cochair Dr. Rob Olson said at present there are 143 ob.gyn. hospitalist groups spread throughout the country, typically with four to six hospitalists each. Most work 12-hour shifts, some 24-hour shifts.

"Right now hospitalists are doing a very small percentage of all deliveries, maybe 2%. I project in 5 years we’ll be doing 20% or 25%," predicted Dr. Olson, an ob.gyn. hospitalist in Bellingham, Wash., and founder of www.obgynhospitalist.com.

The primary mission of ob.gyn. hospitalists is to enhance patient safety in the hospital, he explained. If an emergency requiring cesarean section occurs, the hospitalist can start the operation while the private obstetrician is en route, shifting to second assistant when the private physician arrives and takes over the procedure. Or if a woman who has been in labor for a few hours begins progressing rapidly at 2 a.m., the hospitalist can step in and do the delivery if the private physician can’t get to the hospital promptly.

Hospitalists can also provide support when a midwife or family physician has a complicated delivery requiring a vacuum extraction, forceps, or a cesarean section.

"It’s kind of like being a lifeguard, where you’re sitting at the beach waiting for the problem," he said.

Ordinarily a hospitalist will never see a patient antepartum. The exception is the unassigned patient who may drop in to the hospital with no prenatal care, who then becomes the hospitalist’s responsibility.

Hospitalists also support private physicians by letting them sign out patients as a convenience.

"A private physician may say, ‘I’ve got a big surgery tomorrow. Can you take care of all of my patients between midnight and 6 a.m. so I can sleep?’ That’s another way of utilizing us," Dr. Olson continued.

In the initial months following introduction of an ob.gyn. hospitalist program, however, patient sign-outs typically aren’t a substantial part of the job.

"At the beginning the private doctors are a little worried about it. They don’t want to sign out. They’re suspicious. They’re afraid that they’re going to give up not only their patients but their revenue. When they realize how helpful check outs are, though, then they sign out," he explained.

Some ob.gyn. hospitalists are laborists only and prefer it that way. Others, including Dr. McCue, also cover gynecologic cases in the emergency department.

"I have diagnosed more horrific cancers in 18 months as a hospitalist than in 13 years of private practice," Dr. McCue said, adding that she feels good about covering gynecologic cases in the ER because it enables her to maintain some of her hard-earned gynecologic skills.

Several audience members voiced discomfort about leaving the labor and delivery area to taking on emergency department gynecologic surgical cases because it distracts from the primary hospitalist focus of saving babies. Dr. McCue responded that the answer is to negotiate boundaries.

"What most of the hospitalist programs are coming to is making a deal with the privates," she explained. "You say, ‘I am doing the vast majority of your nighttime work by covering the labor floor for you and covering the first calls for you. All that I ask is that you be available on an emergency basis for the ER overload that I can’t handle. I am happy to get the ectopics and incompletes started for you, but if I call that’s because I need you to be there to cover.’ "

Conference attendees heard best-practice updates from authorities on obstetric triage and evidence-based cesarean section techniques. They also began planning SOGH’s future course. Dr. Bob Fagnant circulated a rough draft of proposed core competencies defining what ob.gyn. hospitalists need to be able to do.

The society will eventually have to formally settle on a group of core competencies, a program for attaining them, and a means of tracking them to attain subspecialty status from the American Board of Obstetrics and Gynecology. The board will want to see evidence that being an ob.gyn. hospitalist requires a special set of skills not taught to physicians who graduate residency as a general ob.gyns., explained Dr. Fagnant, an ob.gyn. hospitalist at Intermountain Health Care in St. George, Utah, who is also vice chair of the ACOG Committee on Ambulatory Practice.

The SOGH leadership believes simulation training will play a key role in demonstrating ob.gyn. hospitalist competencies. Toward that end, SOGH’s first annual meeting featured a half-day of participation in a three-station obstetrical emergency simulation workshop focused on management of obstetric hemorrhage, maneuvers and techniques to relieve shoulder dystocia, and operative deliveries.

Dr. Arthur Townsend, medical director of the ob.gyn. hospitalist program at Methodist Le-Bonheur Hospital in Germantown, Tenn., stressed that hospitalists are "perfectly positioned" to support the quality initiatives hospitals take on to improve outcomes, decrease liability, attract patients, and meet the requirements of outside national organizations that report on quality indicators, such as the National Perinatal Information Center/Quality Analytic Services.

A significant part of what he and his hospitalist colleagues do is gather statistics. These include hospital-wide cesarean rates, vaginal births after cesarean, incidence of episiotomy, third- and fourth-degree laceration rates, postpartum hemorrhage, vaginal deliveries with shoulder dystocia, and a host of others.

He and his fellow hospitalists also carefully track their own performance. They file a detailed online report at a secure website upon completing every shift. These shift reports are compiled into monthly reports totaling the number of deliveries the hospitalists have performed, assists provided at cesarean and vaginal deliveries, the emergencies hospitalists responded to, the number of gynecologic surgeries performed, unassigned patients they’ve seen, and nurse and physician satisfaction survey results. These reports go to the hospital CEO, the board of directors, and the hospital risk management and quality committees.

"We’ve got some data to show that we really make a difference. What we do in these reports is tell how we save people. Everyone wants to know how many patients we’re saving," he explained.

The hospitalists track and submit individual physician-level statistics. When the data point to a problem physician – for example, an ob.gyn. who doesn’t return phone calls from a nighttime nurse in timely fashion or who regularly scores poorly in patient satisfaction – Dr. Townsend leaves it to the hospital quality committee to do something about it.

"I don’t want to be the sheriff," he explained.

These data-filled reports document the progress the hospital has made in achieving safety. This in turn has led to a reduction in the cost of the hospital’s risk insurance. Moreover, when Dr. Townsend made a presentation to the hospital’s risk underwriter, the company was so favorably impressed by what ob.gyn. hospitalists do that it provided them with a $60,000 grant to purchase obstetrical emergency simulators.

Dr. Townsend asked audience members to think about which hospitalist quality measures they consider to be most important yet practical for hospitalist practices to routinely collect at the national level. This is an issue where SOGH would like to be able to provide recommendations.

Dr. Suneet P. Chauhan, a non-hospitalist guest speaker at the conference, recommended focusing initially on two key statistics where he believes ob.gyn. hospitalists could make an impact with maximum "wow" factor: time to cesarean section for nonreassuring fetal heart rate tracings, and time spent in obstetric triage for preterm labor.

"As everyone knows, in one-third of cases the decision-to-incision time in an emergency c-section is not met. The lawyers know that, too. You, more than any other person in the hospital, can decrease the decision-to-incision time," he told the hospitalists.

"You can also really help in obstetric triage. Triage is a very expensive place. In our hospital a patient could be there 3-6 hours before being seen. But if hospitalists routinely adopted the use of transvaginal cervical length measurement and/or fetal fibronectin, it would really shorten the stay at triage," predicted Dr. Chauhan, director of maternal-fetal medicine and professor of ob.gyn. at Eastern Virginia Medical School, Norfolk.

Dr. Frost, the SHM president-elect, shared five key lessons he believes to be essential in building a hospitalist medical society from scratch, based upon the SHM experience: focus keenly on quality improvement; seek to be recognized by external stakeholders as health care reform facilitators, not obstructionists; respect the power of ‘branding" as hospitalists; define your members’ uniqueness; and be an inclusive "big tent" organization rather than exclusive in terms of membership.

ACOG District VIII Chair Dr. Kopelman urged SOGH members to make their viewpoint heard at ACOG by becoming active at the section and district level, then applying for one of the roughly 50 new committee appointments made each year. Natural fits for SOGH members might be the Committee on Patient Safety and Quality Improvement, the Committee on Obstetric Practice, the Committee on Professional Liability, the Precis Advisory Committee, and the Council on Resident Education in Obstetrics and Gynecology.

He also urged SOGH leaders to enroll in ACOG’s Robert C. Cefalo National Leadership Institute.

"It’s absolutely the most valuable thing that I ever did in my involvement with ACOG. It was a career-changing event to have attended that institute," according to Dr. Kopelman.

Dr. Frost noted that the SHM also offers a leadership academy for its members, as well as a practice management institute which provides instruction in hospitalist business operations.

SOGH leaders urged their members to seriously consider belonging to both ACOG and SHM, two organizations having the ear of health policy makers.

DENVER – A cascade of data generated recently by the CONFIRM registry is turning heads and winning converts to coronary CT angiography as a reasonable first-line test to diagnose or exclude coronary artery disease in many symptomatic patients with no history of the disease.

"The CONFIRM information about the need to rethink people’s pretest likelihood of CAD is enormously important. It shows that if we think a patient’s likelihood is intermediate, it’s actually low. So CT angiography might be the least expensive way to exclude CAD," Dr. James E. Udelson observed during a panel discussion at the annual meeting of the American Society of Nuclear Cardiology.

In addition to being less expensive than SPECT (single-photon emission CT) myocardial perfusion imaging for this purpose, CTA also confers less radiation exposure, which is a particularly important consideration given that that the majority of patients undergoing evaluation for symptoms suggestive of CAD turn out not to have it, added Dr. Udelson, chief of cardiology and director of the nuclear cardiology laboratory at Tufts Medical Center, Boston.

Dr. Udelson is not a CT angiographer and is not involved with CONFIRM (Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter Registry). Neither is fellow panelist Dr. John J. Mahmarian. But he too finds CONFIRM compelling.

"I’m really intrigued by the CONFIRM data on nonobstructive plaque. These individuals with nonobstructive atherosclerotic plaque have a good short-term risk but may not have a good long-term risk. With the armamentarium we have today, it’s important to know that so we can treat people more aggressively and impact the disease process," said Dr. Mahmarian, ASNC president-elect and director of nuclear cardiology and CT services at the Methodist DeBakey Heart and Vascular Institute, Houston.

Their comments came in reaction to a wide-ranging update on the registry by CONFIRM investigator Dr. James K. Min of Cedars-Sinai Medical Center in Los Angeles.

Dr. Min explained that CONFIRM is a prospective, multinational registry including more than 32,000 consecutive patients who have undergone CTA at 18 participating sites. The registry was created to answer three questions of fundamental importance regarding the noninvasive imaging procedure: Does it have the ability to diagnose or exclude CAD as well as does invasive coronary angiography? Does it reduce the need for percutaneous angiography? And does it improve health outcomes for patients with acute chest pain who present to emergency departments and other settings?

The answer on all three counts is ‘yes,’ although some of the data are preliminary, Dr. Min said. The registry is being expanded, with follow-up to be extended to a median of 5 years, along with the possible addition of another 12,000-15,000 patients in order to strengthen the findings.

The power of CTA as a risk stratification tool was highlighted in a recent CONFIRM publication (J. Am. Coll. Cardiol. 2011;58:849-60). Dr. Min and his coworkers reported on nearly 24,000 consecutive patients without known pretest CAD who were prospectively followed for a mean of 2.3 years after undergoing CTA for assessment of suspected CAD. These were mainly middle-aged patients with a high prevalence of cardiovascular risk factors. In all, 71% had an intermediate or high pretest likelihood of obstructive CAD.

In this study population, a normal CTA study (found in 43% of patients) was associated with a highly favorable prognosis – namely, an all-cause mortality rate of just 0.28% per year. Moreover, a normal CTA result carried a 4-year "warranty."

Another key finding was that nonobstructive CAD (that is, a 1%-49% stenosis) was associated with a 1.6-fold increased risk of mortality in a multivariate risk-adjusted analysis. Nonobstructive CAD was detected in 34% of subjects.

Mortality risk climbed stepwise with the number of coronary vessels showing obstructive CAD on CTA: a doubling of risk in patients with single-vessel obstructive disease relative to the risk in those with a normal study; a 2.92-fold increased risk in those with two-vessel obstructive CAD; and a 3.7-fold increased risk in patients with triple-vessel or left anterior descending obstructive disease.

The mortality risk associated with obstructive CAD varied by age and sex. Patients younger than age 65 had a significantly greater mortality risk for two-vessel disease than did those aged 65 years or older. The younger patients with two-vessel obstructive disease had a fourfold greater death rate than did young patients with a normal CTA study, whereas older patients with double-vessel disease had a 2.46-fold increased risk. Similarly, triple-vessel obstructive disease in patients younger than age 65 was associated with a 6.2-fold increased risk of death, compared with those who had a normal CTA, a risk twice that conferred by three-vessel obstructive disease in older patients.

The relative hazards for single- and double-vessel obstructive CAD were not significantly different for men vs. women. However, women with three-vessel disease had a 4.2-fold increased mortality risk, significantly greater than the 3.3-fold risk associated with triple-vessel disease in men.

In another CONFIRM analysis, this one involving roughly 8,100 patients with an average pretest likelihood of obstructive CAD of 50% by the widely used Diamond Forrester clinical risk score, investigators found that the actual prevalence of obstructive CAD on CTA was only 18%. The take-home lesson here is that cardiologists severely overestimate the likelihood of significant disease when they rely on clinical risk scores that were developed in an earlier era, Dr. Min emphasized.

Another CONFIRM analysis involved 15,223 patients, 7.2% of whom underwent coronary revascularization following CTA. Among the subgroup with high-risk CAD as defined by the Duke severity categorization criteria – for example, three vessels having moderate stenoses or two with severe stenoses – the mortality rate during an average 2.3 years of follow-up was 2.3% in those who were revascularized, significantly better than the 5.3% rate with medical management.

Thus, it appears that using CTA to identify patients with high-risk CAD results in a therapeutic benefit when such patients undergo revascularization, according to Dr. Min. In contrast, in patients with CTA findings indicative of non–high-risk CAD, mortality rates weren’t significantly different between those who had revascularization and those who had medical management only.

CONFIRM has also showed that CTA reduces the need for invasive coronary angiography. Patients with a normal CTA had a 3-year rate of invasive coronary angiography of 2.5%, and a 0.3% revascularization rate. These rates rose in graded fashion to a 44% invasive angiography rate and a 28% revascularization rate in patients with obstructive single-vessel disease on CTA; a 53% invasive coronary angiography rate and 44% revascularization for those identified as having obstructive two-vessel disease; and a 69% coronary angiography rate and 67% revascularization among patients found on CTA to have obstructive three-vessel or left anterior descending disease.

Dr. Min said that at present there is no evidence-based role for CTA in the evaluation of patients without chest pain or other symptoms suggestive of CAD. And there are better prognostic tests for those with known CAD, he added.

"I must say, looking at it from the outside, it’s really breathtaking how fast the data have grown over the last few years for CT angiography," Dr. Udelson commented. "You in the CT world have, in just a few short years, developed enormous databases it took those of us in nuclear imaging much longer to develop, and you can look at things nuclear can’t, like nonobstructive plaque, where the outcome is different than in people with normal coronary arteries."

Dr. Min has received research grants and is on the speakers bureau for GE Healthcare.

DENVER – A cascade of data generated recently by the CONFIRM registry is turning heads and winning converts to coronary CT angiography as a reasonable first-line test to diagnose or exclude coronary artery disease in many symptomatic patients with no history of the disease.

"The CONFIRM information about the need to rethink people’s pretest likelihood of CAD is enormously important. It shows that if we think a patient’s likelihood is intermediate, it’s actually low. So CT angiography might be the least expensive way to exclude CAD," Dr. James E. Udelson observed during a panel discussion at the annual meeting of the American Society of Nuclear Cardiology.

In addition to being less expensive than SPECT (single-photon emission CT) myocardial perfusion imaging for this purpose, CTA also confers less radiation exposure, which is a particularly important consideration given that that the majority of patients undergoing evaluation for symptoms suggestive of CAD turn out not to have it, added Dr. Udelson, chief of cardiology and director of the nuclear cardiology laboratory at Tufts Medical Center, Boston.

Dr. Udelson is not a CT angiographer and is not involved with CONFIRM (Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter Registry). Neither is fellow panelist Dr. John J. Mahmarian. But he too finds CONFIRM compelling.

"I’m really intrigued by the CONFIRM data on nonobstructive plaque. These individuals with nonobstructive atherosclerotic plaque have a good short-term risk but may not have a good long-term risk. With the armamentarium we have today, it’s important to know that so we can treat people more aggressively and impact the disease process," said Dr. Mahmarian, ASNC president-elect and director of nuclear cardiology and CT services at the Methodist DeBakey Heart and Vascular Institute, Houston.

Their comments came in reaction to a wide-ranging update on the registry by CONFIRM investigator Dr. James K. Min of Cedars-Sinai Medical Center in Los Angeles.

Dr. Min explained that CONFIRM is a prospective, multinational registry including more than 32,000 consecutive patients who have undergone CTA at 18 participating sites. The registry was created to answer three questions of fundamental importance regarding the noninvasive imaging procedure: Does it have the ability to diagnose or exclude CAD as well as does invasive coronary angiography? Does it reduce the need for percutaneous angiography? And does it improve health outcomes for patients with acute chest pain who present to emergency departments and other settings?

The answer on all three counts is ‘yes,’ although some of the data are preliminary, Dr. Min said. The registry is being expanded, with follow-up to be extended to a median of 5 years, along with the possible addition of another 12,000-15,000 patients in order to strengthen the findings.

The power of CTA as a risk stratification tool was highlighted in a recent CONFIRM publication (J. Am. Coll. Cardiol. 2011;58:849-60). Dr. Min and his coworkers reported on nearly 24,000 consecutive patients without known pretest CAD who were prospectively followed for a mean of 2.3 years after undergoing CTA for assessment of suspected CAD. These were mainly middle-aged patients with a high prevalence of cardiovascular risk factors. In all, 71% had an intermediate or high pretest likelihood of obstructive CAD.

In this study population, a normal CTA study (found in 43% of patients) was associated with a highly favorable prognosis – namely, an all-cause mortality rate of just 0.28% per year. Moreover, a normal CTA result carried a 4-year "warranty."

Another key finding was that nonobstructive CAD (that is, a 1%-49% stenosis) was associated with a 1.6-fold increased risk of mortality in a multivariate risk-adjusted analysis. Nonobstructive CAD was detected in 34% of subjects.

Mortality risk climbed stepwise with the number of coronary vessels showing obstructive CAD on CTA: a doubling of risk in patients with single-vessel obstructive disease relative to the risk in those with a normal study; a 2.92-fold increased risk in those with two-vessel obstructive CAD; and a 3.7-fold increased risk in patients with triple-vessel or left anterior descending obstructive disease.

The mortality risk associated with obstructive CAD varied by age and sex. Patients younger than age 65 had a significantly greater mortality risk for two-vessel disease than did those aged 65 years or older. The younger patients with two-vessel obstructive disease had a fourfold greater death rate than did young patients with a normal CTA study, whereas older patients with double-vessel disease had a 2.46-fold increased risk. Similarly, triple-vessel obstructive disease in patients younger than age 65 was associated with a 6.2-fold increased risk of death, compared with those who had a normal CTA, a risk twice that conferred by three-vessel obstructive disease in older patients.

The relative hazards for single- and double-vessel obstructive CAD were not significantly different for men vs. women. However, women with three-vessel disease had a 4.2-fold increased mortality risk, significantly greater than the 3.3-fold risk associated with triple-vessel disease in men.

In another CONFIRM analysis, this one involving roughly 8,100 patients with an average pretest likelihood of obstructive CAD of 50% by the widely used Diamond Forrester clinical risk score, investigators found that the actual prevalence of obstructive CAD on CTA was only 18%. The take-home lesson here is that cardiologists severely overestimate the likelihood of significant disease when they rely on clinical risk scores that were developed in an earlier era, Dr. Min emphasized.

Another CONFIRM analysis involved 15,223 patients, 7.2% of whom underwent coronary revascularization following CTA. Among the subgroup with high-risk CAD as defined by the Duke severity categorization criteria – for example, three vessels having moderate stenoses or two with severe stenoses – the mortality rate during an average 2.3 years of follow-up was 2.3% in those who were revascularized, significantly better than the 5.3% rate with medical management.

Thus, it appears that using CTA to identify patients with high-risk CAD results in a therapeutic benefit when such patients undergo revascularization, according to Dr. Min. In contrast, in patients with CTA findings indicative of non–high-risk CAD, mortality rates weren’t significantly different between those who had revascularization and those who had medical management only.

CONFIRM has also showed that CTA reduces the need for invasive coronary angiography. Patients with a normal CTA had a 3-year rate of invasive coronary angiography of 2.5%, and a 0.3% revascularization rate. These rates rose in graded fashion to a 44% invasive angiography rate and a 28% revascularization rate in patients with obstructive single-vessel disease on CTA; a 53% invasive coronary angiography rate and 44% revascularization for those identified as having obstructive two-vessel disease; and a 69% coronary angiography rate and 67% revascularization among patients found on CTA to have obstructive three-vessel or left anterior descending disease.

Dr. Min said that at present there is no evidence-based role for CTA in the evaluation of patients without chest pain or other symptoms suggestive of CAD. And there are better prognostic tests for those with known CAD, he added.

"I must say, looking at it from the outside, it’s really breathtaking how fast the data have grown over the last few years for CT angiography," Dr. Udelson commented. "You in the CT world have, in just a few short years, developed enormous databases it took those of us in nuclear imaging much longer to develop, and you can look at things nuclear can’t, like nonobstructive plaque, where the outcome is different than in people with normal coronary arteries."

Dr. Min has received research grants and is on the speakers bureau for GE Healthcare.

DENVER – A cascade of data generated recently by the CONFIRM registry is turning heads and winning converts to coronary CT angiography as a reasonable first-line test to diagnose or exclude coronary artery disease in many symptomatic patients with no history of the disease.

"The CONFIRM information about the need to rethink people’s pretest likelihood of CAD is enormously important. It shows that if we think a patient’s likelihood is intermediate, it’s actually low. So CT angiography might be the least expensive way to exclude CAD," Dr. James E. Udelson observed during a panel discussion at the annual meeting of the American Society of Nuclear Cardiology.

In addition to being less expensive than SPECT (single-photon emission CT) myocardial perfusion imaging for this purpose, CTA also confers less radiation exposure, which is a particularly important consideration given that that the majority of patients undergoing evaluation for symptoms suggestive of CAD turn out not to have it, added Dr. Udelson, chief of cardiology and director of the nuclear cardiology laboratory at Tufts Medical Center, Boston.

Dr. Udelson is not a CT angiographer and is not involved with CONFIRM (Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter Registry). Neither is fellow panelist Dr. John J. Mahmarian. But he too finds CONFIRM compelling.

"I’m really intrigued by the CONFIRM data on nonobstructive plaque. These individuals with nonobstructive atherosclerotic plaque have a good short-term risk but may not have a good long-term risk. With the armamentarium we have today, it’s important to know that so we can treat people more aggressively and impact the disease process," said Dr. Mahmarian, ASNC president-elect and director of nuclear cardiology and CT services at the Methodist DeBakey Heart and Vascular Institute, Houston.

Their comments came in reaction to a wide-ranging update on the registry by CONFIRM investigator Dr. James K. Min of Cedars-Sinai Medical Center in Los Angeles.

Dr. Min explained that CONFIRM is a prospective, multinational registry including more than 32,000 consecutive patients who have undergone CTA at 18 participating sites. The registry was created to answer three questions of fundamental importance regarding the noninvasive imaging procedure: Does it have the ability to diagnose or exclude CAD as well as does invasive coronary angiography? Does it reduce the need for percutaneous angiography? And does it improve health outcomes for patients with acute chest pain who present to emergency departments and other settings?

The answer on all three counts is ‘yes,’ although some of the data are preliminary, Dr. Min said. The registry is being expanded, with follow-up to be extended to a median of 5 years, along with the possible addition of another 12,000-15,000 patients in order to strengthen the findings.

The power of CTA as a risk stratification tool was highlighted in a recent CONFIRM publication (J. Am. Coll. Cardiol. 2011;58:849-60). Dr. Min and his coworkers reported on nearly 24,000 consecutive patients without known pretest CAD who were prospectively followed for a mean of 2.3 years after undergoing CTA for assessment of suspected CAD. These were mainly middle-aged patients with a high prevalence of cardiovascular risk factors. In all, 71% had an intermediate or high pretest likelihood of obstructive CAD.

In this study population, a normal CTA study (found in 43% of patients) was associated with a highly favorable prognosis – namely, an all-cause mortality rate of just 0.28% per year. Moreover, a normal CTA result carried a 4-year "warranty."

Another key finding was that nonobstructive CAD (that is, a 1%-49% stenosis) was associated with a 1.6-fold increased risk of mortality in a multivariate risk-adjusted analysis. Nonobstructive CAD was detected in 34% of subjects.

Mortality risk climbed stepwise with the number of coronary vessels showing obstructive CAD on CTA: a doubling of risk in patients with single-vessel obstructive disease relative to the risk in those with a normal study; a 2.92-fold increased risk in those with two-vessel obstructive CAD; and a 3.7-fold increased risk in patients with triple-vessel or left anterior descending obstructive disease.

The mortality risk associated with obstructive CAD varied by age and sex. Patients younger than age 65 had a significantly greater mortality risk for two-vessel disease than did those aged 65 years or older. The younger patients with two-vessel obstructive disease had a fourfold greater death rate than did young patients with a normal CTA study, whereas older patients with double-vessel disease had a 2.46-fold increased risk. Similarly, triple-vessel obstructive disease in patients younger than age 65 was associated with a 6.2-fold increased risk of death, compared with those who had a normal CTA, a risk twice that conferred by three-vessel obstructive disease in older patients.

The relative hazards for single- and double-vessel obstructive CAD were not significantly different for men vs. women. However, women with three-vessel disease had a 4.2-fold increased mortality risk, significantly greater than the 3.3-fold risk associated with triple-vessel disease in men.

In another CONFIRM analysis, this one involving roughly 8,100 patients with an average pretest likelihood of obstructive CAD of 50% by the widely used Diamond Forrester clinical risk score, investigators found that the actual prevalence of obstructive CAD on CTA was only 18%. The take-home lesson here is that cardiologists severely overestimate the likelihood of significant disease when they rely on clinical risk scores that were developed in an earlier era, Dr. Min emphasized.

Another CONFIRM analysis involved 15,223 patients, 7.2% of whom underwent coronary revascularization following CTA. Among the subgroup with high-risk CAD as defined by the Duke severity categorization criteria – for example, three vessels having moderate stenoses or two with severe stenoses – the mortality rate during an average 2.3 years of follow-up was 2.3% in those who were revascularized, significantly better than the 5.3% rate with medical management.

Thus, it appears that using CTA to identify patients with high-risk CAD results in a therapeutic benefit when such patients undergo revascularization, according to Dr. Min. In contrast, in patients with CTA findings indicative of non–high-risk CAD, mortality rates weren’t significantly different between those who had revascularization and those who had medical management only.

CONFIRM has also showed that CTA reduces the need for invasive coronary angiography. Patients with a normal CTA had a 3-year rate of invasive coronary angiography of 2.5%, and a 0.3% revascularization rate. These rates rose in graded fashion to a 44% invasive angiography rate and a 28% revascularization rate in patients with obstructive single-vessel disease on CTA; a 53% invasive coronary angiography rate and 44% revascularization for those identified as having obstructive two-vessel disease; and a 69% coronary angiography rate and 67% revascularization among patients found on CTA to have obstructive three-vessel or left anterior descending disease.

Dr. Min said that at present there is no evidence-based role for CTA in the evaluation of patients without chest pain or other symptoms suggestive of CAD. And there are better prognostic tests for those with known CAD, he added.

"I must say, looking at it from the outside, it’s really breathtaking how fast the data have grown over the last few years for CT angiography," Dr. Udelson commented. "You in the CT world have, in just a few short years, developed enormous databases it took those of us in nuclear imaging much longer to develop, and you can look at things nuclear can’t, like nonobstructive plaque, where the outcome is different than in people with normal coronary arteries."

Dr. Min has received research grants and is on the speakers bureau for GE Healthcare.

DENVER – The historically shaky evidence base for cardiac imaging strategies is in the midst of being shored up by a strong new foundation.

Just a couple of years ago, analysts concluded that cardiac imaging guidelines have among the weakest supporting evidence bases of any of the 53 American College of Cardiology/American Heart Association practice guidelines they looked at. The investigators found that only 2.4% of the evidence supporting the imaging guidelines had a level of evidence of A, meaning supported by multiple randomized trials. Thirty-seven percent of the evidence was level B, coming from multiple observational studies. Another 17% was based on expert opinion, and the rest of the imaging guideline recommendations were not supported by any conclusive evidence (JAMA 2009;301:831-41).

All that is clearly in the process of changing, and in a big way, Dr. James E. Udelson observed at the annual meeting of the American Society of Nuclear Cardiology.

An unprecedented raft of multicenter randomized trials is underway in patients with chest pain. The government-supported studies range in size from 4,300 to 10,000 patients. They are variously aimed at determining whether anatomic imaging via coronary CT angiography (CTA) or functional imaging by SPECT myocardial perfusion imaging stress ECG, or stress echocardiography is the best initial strategy for the diagnosis of coronary artery disease, and at using imaging results to identify optimal management strategies, explained Dr. Udelson, chief of cardiology and director of the nuclear cardiology laboratory at Tufts Medical Center, Boston.

Here’s what’s underway:

• PROMISE. The PROspective Multicenter Imaging Study for Evaluation of chest pain), funded by the National Heart, Lung, and Blood Institute, involves 10,000 patients with symptoms suggestive of CAD and low to intermediate pretest probability of CAD. They’ll be randomized to CTA or functional imaging by SPECT myocardial perfusion imaging, stress ECG, or stress echo, with the study results immediately available to the care team for use in management decisions.

The primary end point is the 30-month composite of death, MI, major complications due to cardiac catheterization, or hospitalization for unstable angina. The study hypothesis is that noninvasive anatomic imaging via CTA will result in superior long-term outcomes.

Enrollment is progressing quickly, with 2,800 randomized patients, according to Dr. Udelson, who is a PROMISE investigator.

• RESCUE. In the Randomized Evaluation of patients with Stable angina Comparing Utilization of diagnostic Examinations, 4,300 symptomatic outpatients are being randomized to SPECT myocardial perfusion imaging or CTA, with their subsequent management being driven by an algorithm based on their test results. The hypothesis here is that CTA will be associated with no increase in adverse events, similar outcomes, lower cost, less radiation exposure, and resultant superior cost-effectiveness. Dr. Udelson is an investigator in RESCUE, which is supported by the Agency for Healthcare Research and Quality and the American College of Radiology Imaging Network.

• ISCHEMIA. The most ambitious of the studies is the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches.

The National Institutes of Health has awarded an $84 million grant to conduct ISCHEMIA, a study of an early invasive versus conservative strategy in patients with stable CAD and moderate to severe ischemia.

The trial involves 8,000 patients with a left ventricular ejection fraction of 35% or more and at least 10% cardiac ischemia. They will undergo blinded CTA to rule out high-risk left main disease or normal coronary arteries. Then they will be randomized to catheterization and revascularization plus optimal medical therapy or to optimal medical management alone with revascularization reserved for worsening symptoms. Follow-up will be for 3-6 years.

ISCHEMIA is designed to provide answers to questions left open by the COURAGE and BARI 2D trials. The key design difference is that ISCHEMIA participants will be randomized to the invasive or conservative strategy before cardiac catheterization. The study hypothesis is that the invasive strategy will prove superior in terms of the primary composite end point of cardiovascular death, MI, or adjudicated hospitalization for unstable angina, heart failure, or cardiac arrest. Secondary end points will include cost-effectiveness and quality of life measures.

Dr. Udelson declared having no financial conflicts.

DENVER – The historically shaky evidence base for cardiac imaging strategies is in the midst of being shored up by a strong new foundation.

Just a couple of years ago, analysts concluded that cardiac imaging guidelines have among the weakest supporting evidence bases of any of the 53 American College of Cardiology/American Heart Association practice guidelines they looked at. The investigators found that only 2.4% of the evidence supporting the imaging guidelines had a level of evidence of A, meaning supported by multiple randomized trials. Thirty-seven percent of the evidence was level B, coming from multiple observational studies. Another 17% was based on expert opinion, and the rest of the imaging guideline recommendations were not supported by any conclusive evidence (JAMA 2009;301:831-41).

All that is clearly in the process of changing, and in a big way, Dr. James E. Udelson observed at the annual meeting of the American Society of Nuclear Cardiology.

An unprecedented raft of multicenter randomized trials is underway in patients with chest pain. The government-supported studies range in size from 4,300 to 10,000 patients. They are variously aimed at determining whether anatomic imaging via coronary CT angiography (CTA) or functional imaging by SPECT myocardial perfusion imaging stress ECG, or stress echocardiography is the best initial strategy for the diagnosis of coronary artery disease, and at using imaging results to identify optimal management strategies, explained Dr. Udelson, chief of cardiology and director of the nuclear cardiology laboratory at Tufts Medical Center, Boston.

Here’s what’s underway:

• PROMISE. The PROspective Multicenter Imaging Study for Evaluation of chest pain), funded by the National Heart, Lung, and Blood Institute, involves 10,000 patients with symptoms suggestive of CAD and low to intermediate pretest probability of CAD. They’ll be randomized to CTA or functional imaging by SPECT myocardial perfusion imaging, stress ECG, or stress echo, with the study results immediately available to the care team for use in management decisions.

The primary end point is the 30-month composite of death, MI, major complications due to cardiac catheterization, or hospitalization for unstable angina. The study hypothesis is that noninvasive anatomic imaging via CTA will result in superior long-term outcomes.

Enrollment is progressing quickly, with 2,800 randomized patients, according to Dr. Udelson, who is a PROMISE investigator.

• RESCUE. In the Randomized Evaluation of patients with Stable angina Comparing Utilization of diagnostic Examinations, 4,300 symptomatic outpatients are being randomized to SPECT myocardial perfusion imaging or CTA, with their subsequent management being driven by an algorithm based on their test results. The hypothesis here is that CTA will be associated with no increase in adverse events, similar outcomes, lower cost, less radiation exposure, and resultant superior cost-effectiveness. Dr. Udelson is an investigator in RESCUE, which is supported by the Agency for Healthcare Research and Quality and the American College of Radiology Imaging Network.

• ISCHEMIA. The most ambitious of the studies is the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches.

The National Institutes of Health has awarded an $84 million grant to conduct ISCHEMIA, a study of an early invasive versus conservative strategy in patients with stable CAD and moderate to severe ischemia.

The trial involves 8,000 patients with a left ventricular ejection fraction of 35% or more and at least 10% cardiac ischemia. They will undergo blinded CTA to rule out high-risk left main disease or normal coronary arteries. Then they will be randomized to catheterization and revascularization plus optimal medical therapy or to optimal medical management alone with revascularization reserved for worsening symptoms. Follow-up will be for 3-6 years.

ISCHEMIA is designed to provide answers to questions left open by the COURAGE and BARI 2D trials. The key design difference is that ISCHEMIA participants will be randomized to the invasive or conservative strategy before cardiac catheterization. The study hypothesis is that the invasive strategy will prove superior in terms of the primary composite end point of cardiovascular death, MI, or adjudicated hospitalization for unstable angina, heart failure, or cardiac arrest. Secondary end points will include cost-effectiveness and quality of life measures.

Dr. Udelson declared having no financial conflicts.

DENVER – The historically shaky evidence base for cardiac imaging strategies is in the midst of being shored up by a strong new foundation.

Just a couple of years ago, analysts concluded that cardiac imaging guidelines have among the weakest supporting evidence bases of any of the 53 American College of Cardiology/American Heart Association practice guidelines they looked at. The investigators found that only 2.4% of the evidence supporting the imaging guidelines had a level of evidence of A, meaning supported by multiple randomized trials. Thirty-seven percent of the evidence was level B, coming from multiple observational studies. Another 17% was based on expert opinion, and the rest of the imaging guideline recommendations were not supported by any conclusive evidence (JAMA 2009;301:831-41).

All that is clearly in the process of changing, and in a big way, Dr. James E. Udelson observed at the annual meeting of the American Society of Nuclear Cardiology.

An unprecedented raft of multicenter randomized trials is underway in patients with chest pain. The government-supported studies range in size from 4,300 to 10,000 patients. They are variously aimed at determining whether anatomic imaging via coronary CT angiography (CTA) or functional imaging by SPECT myocardial perfusion imaging stress ECG, or stress echocardiography is the best initial strategy for the diagnosis of coronary artery disease, and at using imaging results to identify optimal management strategies, explained Dr. Udelson, chief of cardiology and director of the nuclear cardiology laboratory at Tufts Medical Center, Boston.

Here’s what’s underway:

• PROMISE. The PROspective Multicenter Imaging Study for Evaluation of chest pain), funded by the National Heart, Lung, and Blood Institute, involves 10,000 patients with symptoms suggestive of CAD and low to intermediate pretest probability of CAD. They’ll be randomized to CTA or functional imaging by SPECT myocardial perfusion imaging, stress ECG, or stress echo, with the study results immediately available to the care team for use in management decisions.

The primary end point is the 30-month composite of death, MI, major complications due to cardiac catheterization, or hospitalization for unstable angina. The study hypothesis is that noninvasive anatomic imaging via CTA will result in superior long-term outcomes.

Enrollment is progressing quickly, with 2,800 randomized patients, according to Dr. Udelson, who is a PROMISE investigator.

• RESCUE. In the Randomized Evaluation of patients with Stable angina Comparing Utilization of diagnostic Examinations, 4,300 symptomatic outpatients are being randomized to SPECT myocardial perfusion imaging or CTA, with their subsequent management being driven by an algorithm based on their test results. The hypothesis here is that CTA will be associated with no increase in adverse events, similar outcomes, lower cost, less radiation exposure, and resultant superior cost-effectiveness. Dr. Udelson is an investigator in RESCUE, which is supported by the Agency for Healthcare Research and Quality and the American College of Radiology Imaging Network.

• ISCHEMIA. The most ambitious of the studies is the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches.

The National Institutes of Health has awarded an $84 million grant to conduct ISCHEMIA, a study of an early invasive versus conservative strategy in patients with stable CAD and moderate to severe ischemia.

The trial involves 8,000 patients with a left ventricular ejection fraction of 35% or more and at least 10% cardiac ischemia. They will undergo blinded CTA to rule out high-risk left main disease or normal coronary arteries. Then they will be randomized to catheterization and revascularization plus optimal medical therapy or to optimal medical management alone with revascularization reserved for worsening symptoms. Follow-up will be for 3-6 years.

ISCHEMIA is designed to provide answers to questions left open by the COURAGE and BARI 2D trials. The key design difference is that ISCHEMIA participants will be randomized to the invasive or conservative strategy before cardiac catheterization. The study hypothesis is that the invasive strategy will prove superior in terms of the primary composite end point of cardiovascular death, MI, or adjudicated hospitalization for unstable angina, heart failure, or cardiac arrest. Secondary end points will include cost-effectiveness and quality of life measures.

Dr. Udelson declared having no financial conflicts.